# PeptideScanner Drugs@FDA regulatory history - Human explorer: https://peptidescanner.com/regulatory/fda/history/ - JSON object: https://peptidescanner.com/fda-regulatory-history/v1/history.json - Source observed: 2026-08-24T21:23:49.000Z - Reviewed applications: 110 - Approved dated submissions: 1094 - Official document links: 1317 - Source observation SHA-256: `6166fd223ef126a19e8ebfdaafe1fbf7c330a4cf7153cef00fb6c52c45ef757b` ## Reporting boundary This history reports exact Drugs@FDA submission status dates, source-defined action labels, and official document metadata for applications already selected by PeptideScanner. FDA's AP code and action labels are source metadata; this page does not interpret approval scope, reproduce document text, establish safety or effectiveness, or provide medical guidance. ## ANDA074728 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda074728/ - Profiles: Leuprolide - Submissions: 15; documents: 3 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1998-08-04 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74728ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74728.html) | `4b5c75d9d0537f7a01196df783204c62a77254e908b8dc1427b5a26f4c2b2a9b` | | 1998-11-18 | Supplement 1 · AP | Labeling | None listed | `fabc1c27841bfee3f1eb2ad4a51f002a3ede80140ee5e5862f82736f9a1758a8` | | 2001-04-03 | Supplement 2 · AP | Manufacturing (CMC)-Microbiology-Processing | None listed | `6a0f41ffeb56b061d914943a4ad754161d796de220ded795ddcdd857f49da035` | | 2006-09-13 | Supplement 6 · AP | Labeling | None listed | `1be67d86addbf8e661a03d11511d89d96e9d290ea5a02bf1d8a13868ca45fd98` | | 2008-07-06 | Supplement 7 · AP | Labeling | None listed | `84da7c6d6cc162f0055b35b91290faddf421073dfeaed0d4225e315efcabd7df` | | 2011-03-28 | Supplement 10 · AP | Labeling-Package Insert | None listed | `3ad134ec9a2319bfa61dde042c159c96bf23f85f86e6a62a18675e2cb32bec40` | | 2011-09-27 | Supplement 11 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074728s011lbl.pdf) | `a899bfcdf06de6a5d4dded02651584e2ce183fbae5c30f5b8acb0ba9903f96c5` | | 2015-11-17 | Supplement 14 · AP | Labeling-Package Insert | None listed | `57cd74e75947bfeee5582c7308f97d873da122d73e4ba4b6b33797588facf83e` | | 2017-05-19 | Supplement 17 · AP | Labeling-Package Insert | None listed | `b4537a10ab1453d7fa8872a1c5fbd1a0033988a85dab7c23aeb077563c34c232` | | 2017-05-19 | Supplement 18 · AP | Labeling-Package Insert | None listed | `e92ed4ed6e340ea708cff47001827f89ed24775ff9deb56c167afbe1ad378515` | | 2021-02-01 | Supplement 20 · AP | Labeling-Package Insert | None listed | `427b099569da6478dad7a51a44286547348b13c71cadf5fe9873372fd0aa7cd9` | | 2021-02-01 | Supplement 22 · AP | Labeling-Package Insert | None listed | `f9c138b8ae6a81673272524278dfe86c3feda7fb6e82fa4e3dcb9272afb64fd0` | | 2025-09-23 | Supplement 34 · AP | Labeling-Package Insert | None listed | `b5f1910e5eb500e81dc12b9bcf2f5397210c0e5e586118e766aac1a637d291a3` | | 2026-04-30 | Supplement 36 · AP | Labeling-Package Insert | None listed | `c75fca5f1b372cf8bb3e66d50c71c8a1d74537b9f021b37bba00f006ee613488` | | 2026-05-06 | Supplement 37 · AP | Labeling-Package Insert | None listed | `1559120f0d1ffabf32086d60e35c0d08ee87349c6cc5a5950670d3c02f4a84c0` | ## ANDA075471 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda075471/ - Profiles: Leuprolide - Submissions: 13; documents: 1 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2000-10-25 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75471ltr.pdf) | `7ec70b557be97cd31aff220ef638dc8f31e2e02eb7be7ec9ae850caefdee0476` | | 2001-09-20 | Supplement 1 · AP | Manufacturing (CMC)-Control | None listed | `34a6210277238f8cc5f7dafa36de8ed8908269dd1d7e61a76c99337495378357` | | 2009-05-27 | Supplement 7 · AP | Labeling | None listed | `7de7c8a9618cc22feeb1c6f99c9707c7751575bd2a51807ddc7e2925206effb1` | | 2011-03-28 | Supplement 16 · AP | Labeling-Package Insert | None listed | `dcf13151a2089ea67ae02f791648ace37b7329ff7fc88c5081f137537d4706e9` | | 2012-08-09 | Supplement 24 · AP | Labeling-Package Insert | None listed | `0067c8ff5f27e23ee446871f27a5e63c47ab8b15c6dec4e740ee4a3480b99dca` | | 2013-01-31 | Supplement 26 · AP | Labeling-Package Insert | None listed | `1f4b3fa545bffa72a2cf9dc4ea3cfc5427c03712ed6c9ef486661ba8fc6b2eef` | | 2017-05-19 | Supplement 33 · AP | Labeling-Package Insert | None listed | `b511a4ee0b801b36dfceb7d314bcc06aa4f5c3196a529e2309a0854ba6c7db7d` | | 2017-05-19 | Supplement 35 · AP | Labeling-Package Insert | None listed | `6efe507c2fa2c6e6e99148d290ce9dc5c1ab45fe15b73322deef747fae6b6fcb` | | 2017-05-19 | Supplement 36 · AP | Labeling-Package Insert | None listed | `2536f532302591fa5f1609d4bbaa6e8e7ca68d101ab0de533a7693411e757dc2` | | 2025-09-19 | Supplement 37 · AP | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert | None listed | `d2e0665fac2dc3718f3fa12929442be062aff6502821ce35bebb0ba065cde420` | | 2025-09-19 | Supplement 38 · AP | Labeling-Package Insert, Labeling-Patient Package Insert | None listed | `89e3d38cbf4aa83647293de761c6ec819b76be93ff4f5d33dbab2af13ded7132` | | 2025-09-23 | Supplement 45 · AP | Labeling-Package Insert | None listed | `932c9b5fb5cd6f14e39eadada7d90212ea89beb2aa675fb6cbfd3c70c306ab06` | | 2026-05-06 | Supplement 48 · AP | Labeling-Package Insert | None listed | `12cef0b5536a3cafe42f9946f90b29665b82930497c7b601a518ae3a721a09e3` | ## ANDA075721 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda075721/ - Profiles: Leuprolide - Submissions: 1; documents: 1 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2001-11-29 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75721ap.pdf) | `35a33512b87bc310dec247ad9365151d4edb5b7c9d4c77fee064a65a731523eb` | ## ANDA075957 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda075957/ - Profiles: Octreotide - Submissions: 8; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2005-10-03 | Original submission 1 · AP | None listed | None listed | `d79d1d8875177267553277677e83f7cd00a73f28d34809a07bf66d014b886c55` | | 2012-06-28 | Supplement 11 · AP | Labeling-Package Insert | None listed | `bd85df6f8f555708f7baa320c5b661fc14c665a753a5e6e488333962304d8511` | | 2012-06-28 | Supplement 13 · AP | Labeling-Package Insert | None listed | `dcd392c7f424e122c3167bcde0d7e0c42516c3da5195ac92ab60257434c0d0ff` | | 2017-06-27 | Supplement 25 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `60c6ded7c5b2bf8eae60333fe98e567d741afa7571a33fd697bc8ed8f4e1f99e` | | 2019-11-04 | Supplement 28 · AP | Labeling-Package Insert | None listed | `2b43f8b99be6083dea255d3264fadf25882c773000a344fff8f9d548b1995a42` | | 2023-08-08 | Supplement 32 · AP | Labeling-Package Insert | None listed | `dd99fc0cc13a94de33309ae9915800ad76edf654376e3c847bad1b984c0f0b99` | | 2023-08-08 | Supplement 33 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert | None listed | `17417ee78fdca1f295db03d78659d083e4b9c35c5c43a788c6cdc6f082446c03` | | 2023-08-08 | Supplement 35 · AP | Labeling-Package Insert | None listed | `8580b61048abb195c8a5c96ea83a840946ba2f3c9cf6bbfd841b10aef405bd88` | ## ANDA075959 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda075959/ - Profiles: Octreotide - Submissions: 8; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2005-11-21 | Original submission 1 · AP | None listed | None listed | `155de6eefde8d730a0d98ea9a052854c628e01a02cdc8ea8212d9694dd6cd170` | | 2012-07-12 | Supplement 12 · AP | Labeling-Package Insert | None listed | `b3a99ef3f4768efa8b986b82624fdd66a9ffacf6d62b9321a42a4158955c2c8e` | | 2012-07-12 | Supplement 13 · AP | Labeling-Package Insert | None listed | `f8cf549184bb47092c30240882af6cb9ab6166dd4186993d66d8503795850fb9` | | 2017-06-27 | Supplement 26 · AP | Labeling-Package Insert | None listed | `430e8757966401dfa1f158a7c4e3a0348d385b0e8c26516ce9c7b77d2a6d76c5` | | 2019-11-04 | Supplement 29 · AP | Labeling-Package Insert | None listed | `41b1a2a4ac80967aad1b2b2893b1f574d571ccc837277fd05e6034b882357430` | | 2023-08-08 | Supplement 33 · AP | Labeling-Package Insert | None listed | `30f2787a8a905be1c4a87ed4c9c5dbb8ec723cfd9b3cbd2e13c3eb00383190dc` | | 2023-08-08 | Supplement 34 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `39b23a339ec822ca20065ffee63ea9345dbd9797e74e6564ce37409e7a986718` | | 2023-08-08 | Supplement 36 · AP | Labeling-Package Insert | None listed | `1c4cce142d2959de1dc6fccd073e34207d27826676e955974b937d4a77235ace` | ## ANDA076313 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda076313/ - Profiles: Octreotide - Submissions: 8; documents: 1 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2005-03-28 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076313ltr.pdf) | `d26ac650d5abb05c43373b1de2afe2139630c9cea5391f1904d76a2a0c1f419f` | | 2009-03-03 | Supplement 3 · AP | Labeling | None listed | `1b917572612eee5002494c9c09e5d87781e5e5b5d83a6dab9ee9372dc197c768` | | 2013-01-02 | Supplement 8 · AP | Labeling-Package Insert, Labeling-Package Insert | None listed | `75428ed34ca465f901f2dac83636ee0ae81454d27a4dfe7edd7606f5db93c959` | | 2018-08-27 | Supplement 12 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `f44efb372368193e6bdf34ec2fe3c44cf053255019df0340f8f04c8d0f91e995` | | 2018-08-27 | Supplement 13 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `234ccc630e4decb54739296e46940934b62bf7635596470d05fc5727c2415321` | | 2022-09-16 | Supplement 16 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `2871948c2fdaaf825e615dec5afca2818f2d4e0ef0f4ed850a1dda47e3651ca6` | | 2022-09-16 | Supplement 19 · AP | Labeling-Package Insert | None listed | `e5076ce020017b04aa1da0cb9b9df33c2cec093993da9ff69794979664545239` | | 2022-09-16 | Supplement 21 · AP | Labeling-Package Insert | None listed | `31eedcd9dc1b68ce31ce472d5c8aa05d8ff92a4a9073cebb8337f35826f44353` | ## ANDA076330 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda076330/ - Profiles: Octreotide - Submissions: 7; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2005-04-08 | Original submission 1 · AP | None listed | None listed | `05745ffef90b3fb8ae5cb3fc340e3bcc5c83666a9c4e89867cc10ad24a90cba6` | | 2009-03-03 | Supplement 4 · AP | Labeling | None listed | `59695e53933986de89e0c7027db868f30c623dee55bd41a6c0ab4908ba8f5a83` | | 2012-09-12 | Supplement 9 · AP | Labeling-Package Insert | None listed | `2c6b146345468aefc5201ae2f94febe58fe99c556a87a0f55e199eb39de1d886` | | 2018-08-27 | Supplement 13 · AP | Labeling-Package Insert | None listed | `bf3668fe3305f530b0621fa815168bda9ca78a61b1a5d26beda9ddc1ab2d9ad1` | | 2022-09-16 | Supplement 16 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `3652138bce0da889bb1e65531da95fa36d8e3ba90c535845bc9c7a8d8ad5e958` | | 2022-09-16 | Supplement 18 · AP | Labeling-Package Insert | None listed | `58f620000ef48765432f8d536523906a71d77b84b6fec0a392a3e1650fe46338` | | 2022-09-16 | Supplement 20 · AP | Labeling-Package Insert | None listed | `1608be13216da99853cd705037e41e0d91fdd287f671bb1bd0c29d8b64b87f62` | ## ANDA077329 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda077329/ - Profiles: Octreotide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2008-03-04 | Original submission 1 · AP | None listed | None listed | `822aa0fcc7095e69bbcb5d99587df794973c655e2e1477fe8e0c78509c07d531` | ## ANDA077330 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda077330/ - Profiles: Octreotide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2008-03-04 | Original submission 1 · AP | None listed | None listed | `abcf3034390f50d907cad4db16259278cb39873872f3d30aa69dfa7ea13e7ae9` | ## ANDA077331 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda077331/ - Profiles: Octreotide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2008-03-04 | Original submission 1 · AP | None listed | None listed | `9fedf6e4cf982aac394b02a57b45d45e62008a283efd6664e3789ba1315842a7` | ## ANDA077372 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda077372/ - Profiles: Octreotide - Submissions: 4; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2007-08-14 | Original submission 1 · AP | None listed | None listed | `5e4f92cd41edadd08c744c158c7b21aeb670b2f4d46db0c95f44065f8b839d68` | | 2012-11-30 | Supplement 4 · AP | Labeling-Container/Carton Labels | None listed | `cca24c0218305d1a2a979ba5743f8a25201905b6ed67d079489789d3f79ee95a` | | 2013-01-31 | Supplement 6 · AP | Labeling-Container/Carton Labels | None listed | `511dd532e680645c05e962deee809c5b306136192692774dcd1189cbc254c3f2` | | 2017-06-28 | Supplement 10 · AP | Labeling-Container/Carton Labels | None listed | `96ab9d78233a915947ce1015945d248e04464d4fc2c4957f6b85bd9025b3c5ac` | ## ANDA077373 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda077373/ - Profiles: Octreotide - Submissions: 3; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2007-08-14 | Original submission 1 · AP | None listed | None listed | `1799607e47003461b082ffcffa8254262ea4978afb92d37dd33707a83ae80935` | | 2013-01-31 | Supplement 3 · AP | Labeling-Package Insert | None listed | `a24c5c554de937ebb7f051b4b1e8eb18725233d95713e3de8d33a30e47de2d81` | | 2017-06-28 | Supplement 8 · AP | Labeling-Container/Carton Labels | None listed | `768c0d54974ea38cca6154c9b0fcdfdfc61af9821fe45c8d6ac0976536e6313a` | ## ANDA077450 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda077450/ - Profiles: Octreotide - Submissions: 10; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2006-02-10 | Original submission 1 · AP | None listed | None listed | `167e017fd3cbac7e0f1f3c40f9ab1fda3f1a9fde2876909ee958ea40a05a3d0d` | | 2012-11-30 | Supplement 5 · AP | Labeling-Package Insert | None listed | `a4703dc8863916b6a4482cfd981517886491c10c90711c1a754e0d936fca87c7` | | 2018-03-09 | Supplement 6 · AP | Labeling-Package Insert | None listed | `14036e78853521154d791d84ef81997ec065e40dda1cddad526579e6442185d7` | | 2018-03-09 | Supplement 8 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `2c014c906e15a885a920f9f82c5d5ad0d0f410c5c1a8e16d350b6f4edca0edd0` | | 2023-06-30 | Supplement 9 · AP | Labeling-Package Insert | None listed | `0b5a7b134be054dd1f3ac2be84f7570ff14248c60910ed2fa3ff6a1f65324a56` | | 2023-06-30 | Supplement 13 · AP | Labeling-Package Insert | None listed | `e9264f15e121f97dbd67e4f837ec83340f16c8a4cae581f090414d3f836b9e54` | | 2023-06-30 | Supplement 14 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `910fd4928039e2504e4eccd2ee18d1a89bf3e4da113956c230225c1a8a8fd1b1` | | 2023-06-30 | Supplement 16 · AP | Labeling-Package Insert | None listed | `106c11de5f7c0bdd1535b413d1a6c8715fe67aaa9e8bbb08fb987beb560f5add` | | 2024-09-25 | Supplement 18 · AP | Labeling-Package Insert | None listed | `ed76a56a7acb65470479ea45f35636b3e27b4c15420a481a5973cbcdb4106012` | | 2024-09-25 | Supplement 21 · AP | Labeling-Package Insert | None listed | `c083d591d3636ad6c49b315b6afb8a6eeddf1e77bf02d7622c1be922877f4c4f` | ## ANDA077457 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda077457/ - Profiles: Octreotide - Submissions: 10; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2006-02-10 | Original submission 1 · AP | None listed | None listed | `c5ea68562dae82b16fc4d2a4093db322713d9e7fb307e3c48c369d5c9a9e4770` | | 2012-11-30 | Supplement 5 · AP | Labeling-Package Insert | None listed | `a8fe2e73acbaa77bea88afc69877115f468c7316fe7d9a9ab840f97f4ade3316` | | 2018-03-09 | Supplement 6 · AP | Labeling-Package Insert | None listed | `b1b647f39053c8dd956e02c94507425495d4d30158f4b34120e14a7e919a2637` | | 2018-03-09 | Supplement 7 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `98e9a9d7051ca3788f9ff2fbde8598403d9f6463e172289c22d4488a29ffe36f` | | 2023-06-30 | Supplement 11 · AP | Labeling-Package Insert | None listed | `cf028f1c185e9fbc29c590d99792b90b04951d594dad95055a56d5f4bc01a424` | | 2023-06-30 | Supplement 15 · AP | Labeling-Package Insert | None listed | `0e57204dc3dd12bc8a2a1267ba415e07191b5c11c9b902c47a5744c8c9c58d34` | | 2023-06-30 | Supplement 16 · AP | Labeling-Package Insert | None listed | `4121d0dee8b22132bbffa2443bb2c0e2bd90023aa7e722fe7ff576b2b97492c8` | | 2023-06-30 | Supplement 19 · AP | Labeling-Package Insert | None listed | `6485889332bebd7ee9db97eca69e605ecc523e0ddf7eed577fdcf6e0d945b0e6` | | 2024-09-25 | Supplement 21 · AP | Labeling-Package Insert | None listed | `4ad3baf491d7721cf4ecdf3de266f939f95808f52bc2e56a708ef9e137d4ccaa` | | 2024-09-25 | Supplement 24 · AP | Labeling-Package Insert | None listed | `8395dc6a8784eba57e9afc598cc8a2f45bfe89d9dc0ff0ea520ad55f0b9fe62a` | ## ANDA078885 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda078885/ - Profiles: Leuprolide - Submissions: 11; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2009-03-09 | Original submission 1 · AP | None listed | None listed | `f698bd61d29f90e3f3142e2a0ceeb92dda8002d35c36bd02c3f05d968a648254` | | 2011-03-28 | Supplement 3 · AP | Labeling-Package Insert | None listed | `73d57e0a8ce4baa077888b7f14230a8dc81e4e013ed25f19c4e930759a34eaec` | | 2011-04-26 | Supplement 5 · AP | Labeling-Package Insert | None listed | `8397be2424fac5639e288606206f42aabf836184aca893766824087763eaa12b` | | 2015-05-08 | Supplement 12 · AP | Labeling-Medication Guide, Labeling-Package Insert | None listed | `552527cc6ba14328a8641a138d36cf304bf1ff7066f321dd2bed3b7d7e74d6bf` | | 2017-05-19 | Supplement 14 · AP | Labeling-Package Insert | None listed | `bd498e3ebd73810279fa9028892a27d9218c83f84beee3f2f9b0a3392bd6f3e1` | | 2017-05-19 | Supplement 15 · AP | Labeling-Package Insert | None listed | `b19f90aa931c028ce7fa190b8d74a7389bc7fa330a5fdf139dfb5541ab7a0e98` | | 2020-11-20 | Supplement 17 · AP | Labeling-Package Insert | None listed | `ea476407cd98d13552b44246bef5b9340611fbbd5b6aaf913dab20548e037a10` | | 2020-11-20 | Supplement 25 · AP | Labeling-Package Insert | None listed | `6ba4c7c76d3bfa068c3164892efb41f204bb9958ca29f4e66e6e4295c6f9b6f5` | | 2025-09-19 | Supplement 32 · AP | Labeling-Package Insert, Labeling-Patient Package Insert | None listed | `c2c556f3c3638c3d3a66508c64578016e1dc722f96b94c9a0ee109388c4c2867` | | 2025-09-23 | Supplement 39 · AP | Labeling-Package Insert | None listed | `80aea09f8a0204630ff26e39049ff7465428008b47dfae953184509e270436af` | | 2026-05-06 | Supplement 40 · AP | Labeling-Package Insert | None listed | `6da9de11ee0774c71517fa8b01698acd600cb72b301f3003c5ed27ccb466709f` | ## ANDA079198 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda079198/ - Profiles: Octreotide - Submissions: 10; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2011-02-10 | Original submission 1 · AP | None listed | None listed | `afa4d746e1d07c8e1af1d5d20ef9ca0e244001325995d16d7dbbfccaf0df70c2` | | 2011-07-14 | Supplement 1 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `c831c46736d215154e11fa473d96641ec7d401d9bc207327aa2ff00fc6b8227b` | | 2011-12-02 | Supplement 2 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `99288950ec3e0694e0792a1e273661dbcf2e665c67f621bc8fcb8824c1b53851` | | 2013-05-23 | Supplement 3 · AP | Labeling-Package Insert | None listed | `9fb5a219bdac5c9e0ced1d9bde0098d4063a25bb2228a3b6b18048155b37949d` | | 2017-07-07 | Supplement 5 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `60b24c0c3e54a09cde411cc9b56ffbdfe09835c7a2a945e6bd9881b49af90acb` | | 2017-07-07 | Supplement 6 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `261e3fcd50acd2212cba1d163a60862f8fca5b44f0e928384f0edb8f76c53930` | | 2019-09-05 | Supplement 7 · AP | Labeling-Package Insert | None listed | `e22702864e1116eb7c22befb2969072377f4122bd1cdeaba7112f82ea7417d82` | | 2023-02-21 | Supplement 10 · AP | Labeling-Package Insert | None listed | `f6dddc05428b4e0b67cb097a289dd3aaaa9c952ba579e23424cb9c7ceb030e37` | | 2023-02-21 | Supplement 11 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `d47ac582a0cc953eb97e93227bcb60d05edef290e6db1c65544d5035db808c13` | | 2023-02-21 | Supplement 13 · AP | Labeling-Package Insert | None listed | `093f3de194940a085b80edfa5b5ae50b294ad94043a23a1ff8232d42501bd03a` | ## ANDA090834 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda090834/ - Profiles: Octreotide - Submissions: 3; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2013-11-12 | Original submission 1 · AP | None listed | None listed | `1a0fe4a63fb2790da4ee72b67288527b0c752f5008188ae8bd241e6f4e3c1b9a` | | 2017-07-10 | Supplement 2 · AP | Labeling-Package Insert | None listed | `a53b8811b72945cae14de469c59c18043ff4d2d3a3231e088455054b736bf20c` | | 2019-08-27 | Supplement 5 · AP | Labeling-Package Insert | None listed | `61a62281d39ae2ffd0d4305c71d6ced8cd13532b568313ae5e235b5a53ba0d1d` | ## ANDA090985 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda090985/ - Profiles: Octreotide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2011-05-11 | Original submission 1 · AP | None listed | None listed | `a7f5a7aaaedc87b567b3ed045f7ac348f97fe258fc855de7d78777af36e73c89` | ## ANDA090986 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda090986/ - Profiles: Octreotide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2011-05-11 | Original submission 1 · AP | None listed | None listed | `bc332f7d3fbdaa10c22c7ec945afd45590aa2b04a771066f94bf544ddc45480d` | ## ANDA091041 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda091041/ - Profiles: Octreotide - Submissions: 3; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2013-11-12 | Original submission 1 · AP | None listed | None listed | `ee49cea687f9b4049de8f67f806fa4780d530c64a27d887c52ef75ab4b119a2c` | | 2017-07-10 | Supplement 3 · AP | Labeling-Package Insert | None listed | `fb0fdb5ac86393b385690356035092a91fd1bbde96060e5a27b8ee95836c1707` | | 2019-08-27 | Supplement 5 · AP | Labeling-Package Insert | None listed | `0163ef9a946dad3178591f8bcc48106a90a3335190df0e887bab86e03e16d326` | ## ANDA203765 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda203765/ - Profiles: Octreotide - Submissions: 5; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2018-09-07 | Original submission 1 · AP | None listed | None listed | `cb44106edb61ba8fc32178b57d8a6d69144bf8e932a21b82cf90964f1d1cc4a7` | | 2020-02-03 | Supplement 1 · AP | Labeling-Package Insert | None listed | `1c0ddc9dbfdaa015a66507b4c07d2e011d802bdd4160f40bfa1682b39540abd1` | | 2023-02-21 | Supplement 2 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `05b13301648ce1c5bb1f31a2e6b87e1294e71e73dbfb6b101e06ae441414ce6c` | | 2023-02-21 | Supplement 3 · AP | Labeling-Package Insert | None listed | `5d8db856745e4b640174c7e5f7b1f3d6953f86611d027c83c72491b88aeae800` | | 2024-07-09 | Supplement 6 · AP | Labeling-Package Insert | None listed | `82d3a12c1eec21794466cc84fc4e37e65478b1a4454fefb6eab8c6ee600f3a32` | ## ANDA204468 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda204468/ - Profiles: Glucagon - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2024-12-12 | Original submission 1 · AP | None listed | None listed | `ca59d28b40d5bb30fb392b413fd6bf02db3445a90fb1aef0ef5b4f9b4246ed60` | ## ANDA204669 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda204669/ - Profiles: Octreotide - Submissions: 5; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2018-12-27 | Original submission 1 · AP | None listed | None listed | `af23312732e0449dc1b1d714ff78c816960fb032852deb33a118207610f1ab93` | | 2020-02-03 | Supplement 1 · AP | Labeling-Package Insert | None listed | `06656467192a5e54ac1f6bfe4724aa58faa8fe076e73037a929786abacdc5443` | | 2023-02-21 | Supplement 2 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `27eafcc5ed41f6c23eaa0896d276f3db3a964a1e4f98b6a1426e4520dd207583` | | 2023-02-21 | Supplement 3 · AP | Labeling-Package Insert | None listed | `319773223c455382039194ee1970f167173dccb3cea400851395d8cd51458195` | | 2024-07-09 | Supplement 6 · AP | Labeling-Package Insert | None listed | `89c0acb86b0e4a032c649b0a80c943f67de8f41d130be1770dda434d54af4b5f` | ## ANDA206697 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda206697/ - Profiles: Exenatide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2024-11-19 | Original submission 1 · AP | None listed | None listed | `8814ac3f0c98f29010bf08fd460106c96a566cf1c614a24d5990eb5eb2f6c6f3` | ## ANDA208086 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda208086/ - Profiles: Glucagon - Submissions: 1; documents: 1 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2020-12-28 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208086Orig1s000ltr.pdf) | `e645e7dce47a0f84d42a1c261b7614bdad639f7cd1628e4ebc13832b05a2ace6` | ## ANDA208569 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda208569/ - Profiles: Teriparatide - Submissions: 2; documents: 1 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2023-11-16 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208569Orig1s000ltr.pdf) | `1f4394eeacdfe87fc3c49a67535f6db87191d1d93d18bc58a0b3d521c94bfb48` | | 2024-11-06 | Supplement 6 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert | None listed | `66ec3f359dbbc4be72507482fef4b17abab5227eb03748b47ee37f676c0455a3` | ## ANDA209564 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda209564/ - Profiles: Linaclotide - Submissions: 4; documents: 1 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2021-02-09 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209564Orig1s000ltr.pdf) | `cad801b59064a0eddcd7958048b2cc21da6d42ef18c08b90047105383c04e309` | | 2022-05-18 | Supplement 1 · AP | Labeling-Medication Guide, Labeling-Package Insert | None listed | `257881fdaa042d93b1a0bff2cf9d948611135dbc8f74ab5f79e72125bc30dbe5` | | 2022-05-18 | Supplement 2 · AP | Labeling-Medication Guide, Labeling-Package Insert | None listed | `74eded8bd898bd9d12c926bfafcb17d7ad1d8d91e17c8fdb37583de46775f860` | | 2024-07-03 | Supplement 4 · AP | Labeling-Medication Guide, Labeling-Package Insert | None listed | `8cfc2d98c4826882bcda5e0f92d71f16fa9f1b5ded8a3eda09b309cd0e7d3419` | ## ANDA209611 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda209611/ - Profiles: Linaclotide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2023-02-07 | Original submission 1 · AP | None listed | None listed | `eb1af64352528465e11fe73c9de4f7f41f4c61e47902ad2211b440f2f498146d` | ## ANDA210317 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda210317/ - Profiles: Octreotide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2023-12-05 | Original submission 1 · AP | None listed | None listed | `0d6604c809d8c4b1a30cbdfba2f3ccfd9f364a96a77a84f64f4163ba84d871b7` | ## ANDA211097 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda211097/ - Profiles: Teriparatide - Submissions: 2; documents: 2 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2023-11-16 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211097Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/211097Orig1s000.pdf) | `a6770b5dc1e20f63e936de530054f1eb992af8f417177bee0e3c2b0c372ae323` | | 2024-11-07 | Supplement 1 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `c3f2681de57e16e0fa4f8f21d502b435807fd43594b0dbfd1d14ccf06298aa36` | ## ANDA212552 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda212552/ - Profiles: Liraglutide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2026-03-30 | Original submission 1 · AP | None listed | None listed | `9558a81d9ec5057a1961d33e6639a8133739d21d2c7f47dd37553925c099536f` | ## ANDA212963 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda212963/ - Profiles: Leuprolide - Submissions: 4; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2022-06-06 | Original submission 1 · AP | None listed | None listed | `642077a4e07bf81a5837d462e1e1a2df34549d443c0f3c62d5c7493155c3c4b4` | | 2025-09-23 | Supplement 2 · AP | Labeling-Package Insert, Labeling-Patient Package Insert | None listed | `3f493cc0dad91600f973d06575ad4f2f213f264291d86b08f1eef5c9667db515` | | 2026-04-30 | Supplement 3 · AP | Labeling-Package Insert, Labeling-Patient Package Insert | None listed | `0fc9837f9e3c2827b36ea26d01b28871e45198c991cedcebed4338b56a26b227` | | 2026-05-06 | Supplement 4 · AP | Labeling-Package Insert, Labeling-Patient Package Insert | None listed | `9e4f43c1ec145d354c7dfa7d881e0e8d9022df20fec7393f3404afc4adebadc8` | ## ANDA212972 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda212972/ - Profiles: Liraglutide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2026-07-01 | Original submission 1 · AP | None listed | None listed | `72529051e8d04b5bc57915d6190d0bfe4363dbbe3f1aa070979d3e602996b913` | ## ANDA213155 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda213155/ - Profiles: Liraglutide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2026-06-15 | Original submission 1 · AP | None listed | None listed | `d2402e787fee145c5fef3b80c60b134e8d34d02303d4b6bf0a8d7f2a4ae92dd3` | ## ANDA213641 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda213641/ - Profiles: Teriparatide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-12-12 | Original submission 1 · AP | None listed | None listed | `79899972aceb4884e8a358a3021501e21f5fc5bebaa32d44dc8cae954d5e32e7` | ## ANDA213829 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda213829/ - Profiles: Leuprolide - Submissions: 4; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2021-08-13 | Original submission 1 · AP | None listed | None listed | `9b4ec8c942bcc560f5356b7da082d1c1d14807a33f37d2a6de830ac4c95bd9d2` | | 2025-09-23 | Supplement 4 · AP | Labeling-Package Insert | None listed | `5562db9f475ea9a25ed5b3d5260c02025b0230c326eaf64ef4b0203f65e179e3` | | 2026-04-30 | Supplement 5 · AP | Labeling-Package Insert | None listed | `6653c19aa14c6af75df7e64360ec1bfeb9654e242ceb07283fcdaadcb22ac2f8` | | 2026-05-06 | Supplement 6 · AP | Labeling-Package Insert | None listed | `6f7741f57204c02f37078152aca35706e6aa3f1ff28f757f5bb8020dbe45dccf` | ## ANDA214457 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda214457/ - Profiles: Glucagon - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-07-22 | Original submission 1 · AP | None listed | None listed | `0c478cef27630e885630fc6c12d2a1ae179e43f345f08b839329cd263b8b91a2` | ## ANDA214568 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda214568/ - Profiles: Liraglutide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-08-27 | Original submission 1 · AP | None listed | None listed | `bfc09824c95d174a4a515b81ba197e348b5ae4faed1aa8357637b47f60f0b365` | ## ANDA215245 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda215245/ - Profiles: Liraglutide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2026-03-11 | Original submission 1 · AP | None listed | None listed | `496b39e384c5d056ded4421157cf355796c5c21853dd854290adea0dc8448a2a` | ## ANDA215336 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda215336/ - Profiles: Leuprolide - Submissions: 4; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2022-10-28 | Original submission 1 · AP | None listed | None listed | `5b39e449e15ed3d44b1cb78e3add9691025e356986637641608da297b27854e4` | | 2025-09-23 | Supplement 9 · AP | Labeling-Package Insert | None listed | `9842fb55aa7a07210213d9d88a1fffa4da1de7639324f4cf7e320ce0183d9160` | | 2026-04-30 | Supplement 12 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `7c746884bccee62cdaff615e029152110f921b568cf94a451aaa3a15f5e0adab` | | 2026-05-06 | Supplement 14 · AP | Labeling-Package Insert | None listed | `e7fb79ed011c6704ea81769ebbff026cd0c0fbd463a1bd5945fe2b03c34ab100` | ## ANDA215421 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda215421/ - Profiles: Liraglutide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-07-22 | Original submission 1 · AP | None listed | None listed | `5130e4c1799f162c5e17d8f3b2a8f0747efd031a07c5408f0c631ddacd65be42` | ## ANDA215503 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda215503/ - Profiles: Liraglutide - Submissions: 1; documents: 2 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2024-12-23 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215503Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/215503Orig1s000edt.pdf) | `2477c6e58e5444be66e5e058c069d8333fce0e96df97889c25beaed495106624` | ## ANDA215826 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda215826/ - Profiles: Leuprolide - Submissions: 2; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-11-13 | Original submission 1 · AP | None listed | None listed | `9090c133a0a72c0abf0d1d769e5a3e22b3bee12255356044f9cfdf7dab31cd5f` | | 2026-05-06 | Supplement 2 · AP | Labeling-Package Insert | None listed | `2680558c88f0ae8d98d60a18e1b30d1b1e87c56312adb9ab9cba9d1a592b10ac` | ## ANDA216589 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda216589/ - Profiles: Octreotide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-12-12 | Original submission 1 · AP | None listed | None listed | `c6a8a4795f360aca81b8e92e079e32720c52df9b7c9311419b7e950f59ff80fb` | ## ANDA216807 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda216807/ - Profiles: Octreotide - Submissions: 3; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2023-06-13 | Original submission 1 · AP | None listed | None listed | `bfd83b328de4b0e6c4035d76b378c628b403122d222854ca4c73ed4fd11b0214` | | 2024-06-14 | Supplement 1 · AP | Labeling-Package Insert | None listed | `8a1c3ee85dc09af60f45f2d624ee8fee24149b600e7e9220467662ec2d58486b` | | 2024-09-30 | Supplement 2 · AP | Labeling-Package Insert | None listed | `7d4fefccd7c1bdf7390d802b6637a306bec07bd0b15c96b59abbc437c2e0737b` | ## ANDA216839 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda216839/ - Profiles: Octreotide - Submissions: 3; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2023-06-22 | Original submission 1 · AP | None listed | None listed | `6fb509b69d3fe7755462e6f551caa8347d8162478d4a20c6d1d68de9cbea982f` | | 2024-06-14 | Supplement 1 · AP | Labeling-Package Insert | None listed | `3302045ad6dd4ae2ba4f2db59c834d5764114a53c2a38fe446d05bbb37faf7c2` | | 2024-10-25 | Supplement 2 · AP | Labeling-Package Insert | None listed | `e89722cf1548f17daa7cbd679405f0751c3667afb63bbbe412bff9f4967a4294` | ## ANDA217063 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda217063/ - Profiles: Liraglutide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2026-02-24 | Original submission 1 · AP | None listed | None listed | `ccb40664036149db6d5ce17a8d778f712e86d46e237a6f31153c2b56c8369410` | ## ANDA217193 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda217193/ - Profiles: Lanreotide - Submissions: 1; documents: 1 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2024-05-21 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217193Orig1s000ltr.pdf) | `d2e7b340c7dd4c7f04eb24511c4de847bb3f22e33d6fb1281719197a2e03d749` | ## ANDA217234 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda217234/ - Profiles: Liraglutide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2026-02-24 | Original submission 1 · AP | None listed | None listed | `bf77b244175270a5c11f28ecb0f76df5acc5fef5fc877881d34feaaf97c632b9` | ## ANDA217437 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda217437/ - Profiles: Leuprolide - Submissions: 2; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-06-09 | Original submission 1 · AP | None listed | None listed | `c57301196f464607037973f7278c765c707a7b809e3dc3be5f5b3937e3a52eb5` | | 2026-05-06 | Supplement 2 · AP | Labeling-Package Insert | None listed | `76a1fde66d2fb1f56e7b94f8d00f0ff79ff0ab45266ef5c81ee99b3a0766f29a` | ## ANDA217590 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda217590/ - Profiles: Liraglutide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2026-01-14 | Original submission 1 · AP | None listed | None listed | `97ee37f291805347bcb5e4b11e4efba68ee4bcc48e596e0c6bd6fe1508edc66c` | ## ANDA217860 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda217860/ - Profiles: Octreotide - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2024-05-02 | Original submission 1 · AP | None listed | None listed | `84fd19f0500ce6712cf46779948a1a153c09be4f458e62bff2d31b4f00b3cac1` | ## ANDA217957 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda217957/ - Profiles: Leuprolide - Submissions: 4; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2024-10-17 | Original submission 1 · AP | None listed | None listed | `abbba7831d1f05c3497be577c005d9a415e2f2da0c6a34518be6c36114d5d76b` | | 2025-09-23 | Supplement 2 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `fa57049113b49fc1d9dc08b31ae817cafebd6c9838f8069a9c9cd8e6b6544cf8` | | 2026-04-30 | Supplement 4 · AP | Labeling-Package Insert | None listed | `45422be0c55ad4da8a8675c379707163a05794a958a4ecf8bbc3e78a1002c49a` | | 2026-05-06 | Supplement 5 · AP | Labeling-Package Insert | None listed | `4f16e9bf1d466fddda4ec7df9e47aa9e7ce94fda4b0ba6c01ecf498a9d2968d9` | ## ANDA218115 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda218115/ - Profiles: Liraglutide - Submissions: 2; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-04-02 | Original submission 1 · AP | None listed | None listed | `fddccc7781a4be17e66a3034d0304660b58e040e4e29761ffb8fa712da3376ea` | | 2025-10-15 | Supplement 3 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `fbb470eebed9c5f5f746006f48528fd5ac80c96ba7e08373ba54ca524306257d` | ## ANDA218813 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/anda218813/ - Profiles: Glucagon - Submissions: 1; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-09-15 | Original submission 1 · AP | None listed | None listed | `84bcc97fb690f7198e963828689aaca61d161c0a891a3328e8d1d619862374d0` | ## BLA022505 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/bla022505/ - Profiles: Tesamorelin - Submissions: 12; documents: 19 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2010-11-10 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022505s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000TOC.html), [Summary Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000SumR.pdf) | `2e3f2dde65bac6c5ceae19d81c039edf64fcf9f477383c97bf46d34f87ecd5e7` | | 2011-11-29 | Supplement 1 · AP | Manufacturing (CMC) | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf) | `5b3725d181a7f1389e70ab6a32be3d2547940bf3d9bc159fbdcac1b2d98ee094` | | 2011-11-29 | Supplement 3 · AP | Labeling-Patient Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf) | `aed8be22e052577f5afb3d4a051415329440f91a6411e14159cfa29e60f50de7` | | 2013-01-07 | Supplement 4 · AP | Labeling-Medication Guide | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022505s004lbl.pdf) | `12e1f25b6b38bfda1874b7765ac85d3660f329b4c9e079b6dfa616c436f26046` | | 2014-12-15 | Supplement 5 · AP | Manufacturing (CMC) | None listed | `9817306e59872bc94a1a0f78f6dafab061ec11d055efeb1f2da73f4becb925cf` | | 2015-02-09 | Supplement 6 · AP | Manufacturing (CMC) | None listed | `0a0852de3215c3d95857b6c5a82d12fb7a0e361f3a7d05f448cfbda258bc8a66` | | 2015-06-08 | Supplement 7 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022505Orig1s007ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022505s007lbl.pdf) | `d77e5e428e0e04bdb7b3498bcf75cfb20759b237036fc7981914113a2a8e6a9b` | | 2019-01-18 | Supplement 11 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s011ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s011lbl.pdf) | `c0a838d9de691adab7d2f778c0403e721f9032dbcba6b064834827d06db7d8d2` | | 2019-07-05 | Supplement 12 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Proprietary Name Change | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s012,%20s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf) | `e5c4b811ec1896e2f12f32b071200d80fa81f687735a7d8b08aca3822873a560` | | 2019-07-05 | Supplement 13 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s012,%20s013ltr.pdf) | `fbbab2b97ed498b26ff1e1e8a7b78ea19f4d05d2127e2871ff5703a2d0e6da03` | | 2024-02-27 | Supplement 18 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022505Orig1s018ltr.pdf) | `a318cd0015c69bbaeeb8e7b9e68023d10851be906d2c57b472fba58f2b16f908` | | 2025-03-25 | Supplement 20 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf) | `2036f3251a22daf80294bf4fdd26a968c7d382baf5830ae688e3242822189cf9` | ## BLA125469 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/bla125469/ - Profiles: Dulaglutide - Submissions: 22; documents: 42 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2014-09-18 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000Lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000TOC.html), [Summary Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000SumR.pdf) | `24edeab042d1ae60a233421454d802f22fed162976d0b10ec4bbf54a0896e04f` | | 2014-12-19 | Supplement 2 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s002ltr.pdf) | `b4ab3aa6b0ed60fe5743a608d23c6e6b1454575a7c73c39339da3bae877d38b1` | | 2015-03-09 | Supplement 1 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s001ltr.pdf) | `1d16e51150bf9e6ea2b9cc397bb879b651f891d064624d3894f2ae52a369d06c` | | 2015-07-27 | Supplement 4 · AP | REMS-Modified | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s004ltr.pdf) | `f621fb5f25ef51235ebbcbfcd7bdbed9c190a3ef7dd7ac0f93ffa13938e4062c` | | 2017-01-27 | Supplement 7 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf) | `47f995411707e8ae9575e1cfe465425cf6a13c757c2be3aa969fa91deaecb0c9` | | 2017-01-27 | Supplement 8 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf) | `ec36d61616711909a018c358ae9b45061616309b5aa8b2ee15a0aac2d3a084ae` | | 2017-08-01 | Supplement 11 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf) | `8cf188269f4844bcc5410becf0ce5aae8e413993beda819cab4a3e24a8229784` | | 2017-08-01 | Supplement 13 · AP | Labeling-Medication Guide | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf) | `eab1d772d250108d9a39220bb5beecb2f882c93c09c66179546d78a559886025` | | 2017-12-12 | Supplement 21 · AP | REMS - MODIFIED - D-N-A | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s021ltr.pdf) | `254cc49056f13a278d7bcb64ecfaf56bcce9b98b815112b010cbbad96ca84e02` | | 2018-06-29 | Supplement 17 · AP | Efficacy-Accelerated Approval Confirmatory Study | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s017ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s017lbl.pdf) | `b0fc3bb1a46dc855d8d1b2584e15c32ceaaca3666740c0a1508f77b67884101e` | | 2018-09-21 | Supplement 24 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s024ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s024lbl.pdf) | `e88a828af16b2b49470146a461db185d83a8ba15c9bd0006ae6aea63917af785` | | 2019-01-15 | Supplement 23 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125469s023lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125469Orig1s023ltr.pdf) | `95b16efa31b77c4c69df6b66bf30721cdbe50ef5fea9dd9b5d48d19f0ca5642c` | | 2020-02-21 | Supplement 33 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s033lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125469Orig1s033ltr.pdf) | `90d0fa6f3afaa8d46b5c14e45acbb7f95c6cfe4b99a71e1978422606b6c9495c` | | 2020-09-03 | Supplement 36 · AP | Efficacy-New Dosing Regimen | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125469Orig1s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s036lbl.pdf) | `a35db1158c58a7ab944baee0a6fc4eff7cd09f0716feca05909e2475f7d83486` | | 2021-09-30 | Supplement 44 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125469s044lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125469Orig1s044ltr.pdf) | `569c0fe3f633f4c6f9239586f323560433d3ea96aa3768bbb86b66e9359b00ed` | | 2022-06-10 | Supplement 46 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s046,%20s052ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf) | `f7cefc790b85f71feb8b8a8fd0a817b906c022e72dbcd9beead9d7329b7500aa` | | 2022-06-10 | Supplement 52 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s046,%20s052ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf) | `075e37fdfa81f83fb887a626f17e891ec05dc3f737f94f27670cdbea3e772ed7` | | 2022-11-17 | Supplement 51 · AP | Efficacy-New Patient Population | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s051ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf) | `348e30fd8918f8d2a65e3e4a2388a550af5bb26da5293ea9ef6ce89525fedbf1` | | 2024-11-01 | Supplement 61 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125469s061s062lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125469Orig1s061,%20s062ltr.pdf) | `b3b8c63bf0de16dc6dd830009dc3aad55ffadbae61a481fe628defd2617c3cd2` | | 2024-11-01 | Supplement 62 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125469s061s062lbl.pdf) | `c1b48c65d6c56e28ad3d78e6094b7fc898e46a43d49fcf310439ca1964a575a0` | | 2025-05-28 | Supplement 63 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125469Orig1s063ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf) | `2cf9f8ab50ccf6a61aed9f554a7ddcc871359a5d37d98c095d199fb42a29b3db` | | 2026-03-12 | Supplement 65 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125469Orig1s065ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125469s065lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125469s065lbl.pdf#page=32) | `24745353cc54aa7de1e26bd79079448c2e1c59201ffabb5cb6399f0b9368d1f7` | ## BLA208471 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/bla208471/ - Profiles: Lixisenatide - Submissions: 7; documents: 16 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2016-07-27 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208471Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208471Orig1s000TOC.html) | `84568e2675f2e7c3ba5967836153fff09a28f0f8f79947b77ca0000e15665402` | | 2021-07-30 | Supplement 4 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208471Orig1s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208471s004lbl.pdf) | `821f2d803a657ea7dad40fa3556b5a63bf3105db905cc5b393f54951c46b3aa2` | | 2022-06-10 | Supplement 5 · AP | Labeling-Package Insert, Labeling-Patient Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208471Orig1s005ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf) | `5b8e1f0c680f01e5d0b34cf5b75120f9b6943e002c6af7a3045ff3e72c669d01` | | 2023-09-28 | Supplement 7 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208471s007lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208471Orig1s007ltr.pdf) | `1c10c3631ef8107bcf195b6c9c692f4d6dce77a83999bbb8af0b5e13e7b00fee` | | 2024-11-01 | Supplement 9 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208471s009lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208471Orig1s009ltr.pdf) | `3adb3be5200732550d69e48394bfdcbd790cbf982bfb6b9e8b2cca41fd1399b9` | | 2025-05-28 | Supplement 10 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208471Orig1s010ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208471s010lbl.pdf) | `5cb65508fde6ac3f17a17e8aee86e921ef4ff29fa905a1c0da2fd61e23381ba4` | | 2026-03-12 | Supplement 12 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208471Orig1s012ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208471s012lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208471s012lbl.pdf#page=25) | `9248bf88d36a16982a9037e8e9ebb56d6b8f93bb43d7c5181708bef6872b2924` | ## BLA761412 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/bla761412/ - Profiles: Insulin glargine-aldy - Submissions: 1; documents: 2 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2026-04-29 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761412Orig1s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761412Orig1s000ltr.pdf) | `843af8c57c51a7025c2251a9d81e44d2f5292b9a9b1eed47804bed24e84bcfce` | ## NDA012122 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda012122/ - Profiles: Glucagon - Submissions: 31; documents: 0 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1960-11-14 | Original submission 1 · AP | None listed | None listed | `a8291deb2cafe1155137825943e0698a85b3d0674b2e06a0889bfed5fe8cee3f` | | 1975-01-27 | Supplement 9 · AP | Manufacturing (CMC)-Control | None listed | `8291df503c6b482b472116a7c2eb5a25018809ccbe0bbae358ead5d3d7b6c163` | | 1975-05-20 | Supplement 8 · AP | Manufacturing (CMC)-Control | None listed | `5a678446e33e5b8d393a418c71ff8fdd3a74453e64c0fde4e1d385a5c700c4ba` | | 1975-12-31 | Supplement 10 · AP | Manufacturing (CMC)-Control | None listed | `8132f4c88544c30f117428d33a74e87032c11e7ee3d6393108f7ec57d1e443e5` | | 1979-11-27 | Supplement 12 · AP | Efficacy | None listed | `a85a68cf78f4f53d778a895964f711c61c943332f52b5a579c3f178826cb3e63` | | 1980-02-21 | Supplement 13 · AP | Efficacy | None listed | `4d306044adcec5fe461c4e3d4112181e4e575772da0109e5e1712b2f5f287196` | | 1981-06-15 | Supplement 14 · AP | Efficacy | None listed | `b3afdd7ce1be5e788b83f7e43bd2c8c1d4e55e4430fa374205a1383a9eb2ee25` | | 1981-10-09 | Supplement 15 · AP | Manufacturing (CMC) | None listed | `a962c303bf71266ff3f31df21820be5a241183096981f3b56a52b379a99bdbd4` | | 1983-07-21 | Supplement 16 · AP | Labeling | None listed | `1a41758415adcae86e5b4f391a58437612ad56cd224dd6439d37a916edf3229c` | | 1984-08-02 | Supplement 17 · AP | Manufacturing (CMC)-Control | None listed | `b4118671b1d942826b62e919f36aceff0eb5dc27905f7239b026e6ca93c76615` | | 1984-08-09 | Supplement 18 · AP | Labeling | None listed | `95af08b85575d70e5ee3e52dba65ff2b36a4fb60285ee6831ca5a6ea3ceab79c` | | 1984-12-13 | Supplement 19 · AP | Labeling | None listed | `db689c25aaa0241ddd3b22784397d0aab91391da725f898db3ddd0cadc924210` | | 1986-09-30 | Supplement 25 · AP | Labeling | None listed | `45b604b151fc3ddcb46b609876240974f427fc6a9498299c9dad497aa7838328` | | 1988-01-05 | Supplement 27 · AP | Labeling | None listed | `876fcd23a67a9ea1571e0c9e47ce70d3b41cfc6972158877ab07c64726b898ce` | | 1988-09-30 | Supplement 28 · AP | Manufacturing (CMC)-Packaging | None listed | `4cfd489703f5ef12ae6d7024d652b120a0b79c06277c3ca3ba7d01ec566782ea` | | 1988-12-02 | Supplement 29 · AP | Labeling | None listed | `20e49df17e8e807c46d03b30232eee19a0415e976cf77751fde46fb796f8fa84` | | 1990-10-01 | Supplement 32 · AP | Labeling | None listed | `4aa34993f40094fb4fcc0219c129cac2caaa5d0b3ac6823cca9a3a05dc21a12c` | | 1990-10-04 | Supplement 30 · AP | Labeling | None listed | `2e5d2c6ca2adfa012e7ea4f1b40d5280b8d8385c380915c4f01a4daf870b856d` | | 1990-10-11 | Supplement 31 · AP | Labeling | None listed | `0633063b241a42052ecfbaff79aeaeecd231ab0d97e091e7f0af217cf2dd075d` | | 1991-04-03 | Supplement 26 · AP | Manufacturing (CMC) | None listed | `fb78e9b0bbf843a26e8f132d02b5896de6621d4e3c38edb4b7d3276069c94927` | | 1991-11-19 | Supplement 33 · AP | Manufacturing (CMC)-Control | None listed | `216ff34d3fe42966d8de6e1586d652083bc5334978956e86994aae05bb04dadb` | | 1993-04-28 | Supplement 34 · AP | Labeling | None listed | `8d6fcfa2aff70e792af33fc111a6587f8c156f0ea9fdff8c1b137c0e25cf9d89` | | 1995-12-15 | Supplement 36 · AP | Labeling | None listed | `a5a7918431eb84ff6698f8fe52998768ae4319aff09410e15dc6b8ccde8d3ad7` | | 1996-04-19 | Supplement 35 · AP | Manufacturing (CMC) | None listed | `98f7662e5c53cc6227ad1019c0449e813f3aa8f05b3b108324794c57e61b21b3` | | 1996-11-07 | Supplement 38 · AP | Manufacturing (CMC)-Control | None listed | `383aac4a4839ba1055f9812415eacd18f82a5d5fbe3eb70d8ccc7d0c8494b077` | | 1996-12-13 | Supplement 37 · AP | Manufacturing (CMC)-Control | None listed | `0cc032e633bdc2a36f4637ee99a0957749d417ebf912d8393ed8ab312f83d1c9` | | 1997-04-18 | Supplement 40 · AP | Labeling | None listed | `4e260565a32b4e8786b18a13c3082d8a09d2a8327ef2d63f3cf28e1c83ed3d0a` | | 1997-05-12 | Supplement 39 · AP | Labeling | None listed | `f21091533df6a6624d5fc890af301dac650faddbb81b6e22a1daf5ac872d1436` | | 1997-09-23 | Supplement 42 · AP | Manufacturing (CMC) | None listed | `55f0422fa2b60754614b54ba96c40e9722b626fbfa55d8d6f26487a3d64ad727` | | 1998-01-08 | Supplement 41 · AP | Manufacturing (CMC)-Control | None listed | `491c33af4a8ccedba3e76e5ec2d6fc42a7175ec8b55e47355d974c9668b48607` | | 1998-06-26 | Supplement 43 · AP | Manufacturing (CMC)-Control | None listed | `9274e149e9d79eb96c0ebeb781420907128a5e3405813cec86ef18ab855029ad` | ## NDA019010 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda019010/ - Profiles: Leuprolide - Submissions: 35; documents: 32 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1985-04-09 | Original submission 1 · AP | None listed | [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019010Orig1s000rev.pdf) | `42635a8864542dfddddeb50e51c3d9573ce1c858da134f562af710d46eb3da91` | | 1986-07-10 | Supplement 2 · AP | Manufacturing (CMC)-Control | None listed | `7d425161f826cc10c22b6e5101daf9507f9d8a0016caf8a41b1d8632000bf6a3` | | 1987-01-14 | Supplement 5 · AP | Manufacturing (CMC)-Control | None listed | `f409fb140d4a6e6d359a192c65848dcfc44efd4a474fa08055ed33b53f065dfe` | | 1987-03-12 | Supplement 4 · AP | Labeling | None listed | `8ec729bffcff040a96e5e0caf8286f0880939b456743e1c404587729c5450248` | | 1988-01-19 | Supplement 3 · AP | Manufacturing (CMC)-Control | None listed | `44a490bda72ff0cb970e967b6da4c57fc621fa408ee340ab47084f1a0564ca2a` | | 1988-05-09 | Supplement 6 · AP | Manufacturing (CMC)-Formulation | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019010_S006_Lupron%20Injection_APPROVAL%20PACKAGE.pdf) | `dab9fa6196f7c389fae0ba8328d51ce6daf8d01115faef2cc1778e83a5fe7afc` | | 1991-10-21 | Supplement 8 · AP | Manufacturing (CMC)-Control | None listed | `4607f6f7c63e431214c8998edcbf158de8c1484f224566beb725717a40dec3ed` | | 1992-07-07 | Supplement 9 · AP | Manufacturing (CMC)-Control | None listed | `6dab35f164a41a5b06cec8d1b65a51673bbe7bcadf6859d21965c0478b1fa8e7` | | 1993-06-09 | Supplement 10 · AP | Manufacturing (CMC)-Control | None listed | `15b7b4c39cd9d794fd4477ad88e677f78cc0ae2bf3841afc1c444327834f6520` | | 1994-05-09 | Supplement 11 · AP | Manufacturing (CMC) | None listed | `79ce90c19b034fa2b54cd59a146cc1a46bddb13b4819cceeee348434d2b1547d` | | 1994-05-09 | Supplement 12 · AP | Manufacturing (CMC)-Control | None listed | `bdb78a8214c3a736877db53bd296ae4ccf5a832661ab4063b677b02e3be03be6` | | 1996-04-24 | Supplement 14 · AP | Manufacturing (CMC)-Control | None listed | `c7be7332b91db1f3f952d6ae0935a783a974df430d7e5adb0b2d0b5c8ad2af92` | | 1996-05-28 | Supplement 15 · AP | Manufacturing (CMC)-Control | None listed | `dd97da02d0202a94703ebbc54515548b0cff0f9c29db3e359439171958a98f2f` | | 1997-07-07 | Supplement 17 · AP | Manufacturing (CMC)-Control | None listed | `325f436b942efecd1f5169e21be4f225411fb4a107b6d353fb25acd6b33d35e5` | | 1997-07-07 | Supplement 18 · AP | Manufacturing (CMC)-Control | None listed | `8d6932da620b5259dc3d0a916f7b8832a8c53c55d3dd27b7273626c25d79fa4b` | | 1998-01-08 | Supplement 19 · AP | Manufacturing (CMC)-Control | None listed | `7fd9fce3aae54087f2a334abe30dc3c51b483866826979c701f45b45dbaea54e` | | 1998-09-25 | Supplement 20 · AP | Manufacturing (CMC)-Control | None listed | `6dc6a651c14f55f66f79121beb52a5845e8dbaf1605620ac12364ba556553c10` | | 1999-11-22 | Supplement 21 · AP | Manufacturing (CMC)-Control | None listed | `90725806ef5f5bc1e2215b887a7f01552a683ce55d89541b56cc55b634960ee8` | | 2000-12-21 | Supplement 22 · AP | Manufacturing (CMC)-Control | None listed | `1bc771b10997e86bb2deb843795a5913ff15127cdb112a343f0d4e31a91357a2` | | 2002-05-16 | Supplement 23 · AP | Manufacturing (CMC) | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S023_Lupron%20Injection_APPROVAL_PACKAGE.pdf) | `b7f0b13bde32ff103965c7446ded7b766b0bca3a4ea1b3c151933d250aa191ef` | | 2002-05-16 | Supplement 24 · AP | Manufacturing (CMC) | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S024_Lupron%20Injection_APPROVAL_PACKAGE.pdf) | `ed6f22302376920a48f54ad40e7eae41ad7b4a6d88bd77ca18186ebcf11d87d9` | | 2003-11-25 | Supplement 27 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19010slr027ltr.pdf) | `b58777c3450ef0d71d15471e0ea704ebf29931d1ba0588a505d51acd8172e6e1` | | 2004-10-18 | Supplement 28 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19010s028ltr.pdf) | `91d523ef0dda639286b295d93411b658b7768f4855caadd1298b0161b75ec8d8` | | 2005-09-15 | Supplement 31 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019010_S031_Lupron%20Injection_APPROVAL_PACKAGE.pdf) | `944e7d9d35dda117b9a94ec8121d21ebc82bf6f2f5a4b36cb528834a701546ba` | | 2007-09-14 | Supplement 32 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019010s032ltr.pdf) | `028b8c2b1f472c108550ed1728dad7004c1f611f49bb8ee49735161859e256df` | | 2010-04-28 | Supplement 33 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf) | `927f48d7f122eb98321885b54129e54df4a9b2f73e4d1e84f0ee5a702d40b24d` | | 2011-01-14 | Supplement 36 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/019010s036,019732s037,020517Orig1s031ltr_C.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s036lbl.pdf) | `d5073aeaa8a65eb744b6ec7d758658fd5d50554d1b11c60d1191b67c93a8cfb6` | | 2011-03-21 | Supplement 35 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s035ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s035lbl.pdf) | `3d726c1570da67db54fc6a749edf0925063014d8032be5a8dae7908e90622070` | | 2014-07-10 | Supplement 37 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019010Orig1s037ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019010s037lbl.pdf) | `50dc2d26185bc1d8220552d217b55ad0c420a0096a701daff1deb4efaf2e4a58` | | 2017-05-19 | Supplement 38 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s038lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s038lbl.pdf#page=27), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019010Orig1s038ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/019010Orig1s038.pdf) | `f1280bf031672f8f4e7a31c370fddf606812571face0124327a6d0d53458346a` | | 2017-07-11 | Supplement 39 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s039lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019010Orig1s039ltr.pdf) | `53050a3c3b102600613ca8bea6a3e99a1c00c5c94aada763a17bd9ab0e21f7e6` | | 2018-12-10 | Supplement 41 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019010Orig1s041ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019010s041lbl.pdf) | `9dac6522035ebc397107b7535139aa3e09196141c5346905372a00c41d19d64e` | | 2025-09-23 | Supplement 43 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019010s043lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/19010Orig1s043ltr.pdf) | `c23c88ade5b0fd43f7d376edbf006722fc93233b54eca2b17ac083f9132932b0` | | 2025-09-30 | Supplement 42 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019010s042lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019010Orig1s042ltr.pdf) | `3cb99ef37f53ecce07c1d43595d3c8665d59f065a935b55aac1fd63c6dfdb70a` | | 2026-05-06 | Supplement 44 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/019010Orig1s044ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019010s044lbl.pdf) | `4f930166dd56148b659aad149b297b1f751f2e3721c94f9a332457f6b3d7b983` | ## NDA019667 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda019667/ - Profiles: Octreotide - Submissions: 50; documents: 29 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1988-10-21 | Original submission 1 · AP | None listed | None listed | `bb7ee09a373aadd223c40e41d04eab9232935abc28ad9cca73897ddff5977dbc` | | 1989-06-23 | Supplement 3 · AP | Manufacturing (CMC)-Control | None listed | `88a95e488af331e37eb03779516cb2ec1f1c4aad9851bd95f9243c5573ab2688` | | 1990-04-16 | Supplement 5 · AP | Labeling | None listed | `7e3f04bd01757ad43a39dc73938c1c004b8c219485f13e682b7ba6ef11d89571` | | 1991-06-12 | Supplement 4 · AP | Manufacturing (CMC)-Control | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019667-s04.pdf) | `9b9a1154a47f7e66f247262594f7e0e27abca07b31d7678795ef4f10eadc346a` | | 1991-07-03 | Supplement 7 · AP | Labeling | None listed | `e174d97c74f9df61b47c61e51377a165150703af3d0913b928fa5b25b3cd1502` | | 1991-10-04 | Supplement 8 · AP | Labeling | None listed | `c290b96d48e72fffda6a2c04a948ee749b2c28ef0153819e1a753dd9f8a4d784` | | 1992-02-28 | Supplement 10 · AP | Manufacturing (CMC)-Control | None listed | `729bc7773f5871fae95e6a3379daef65b39bfa76b215f06adf61cab52d98f2d3` | | 1992-07-31 | Supplement 14 · AP | Labeling | None listed | `1ea3ef36a600683a04032f275eecd3c0f1d57679e32d95153f84198471496cb0` | | 1992-09-30 | Supplement 15 · AP | Manufacturing (CMC) | None listed | `ec3c74044eb81f4b2e4df544e68ac73deb3131165b6122563489cb4ff2d9fa47` | | 1993-01-12 | Supplement 16 · AP | Manufacturing (CMC)-Control | None listed | `72984392f03b41f524cc055141c264cda56aff33dd2bee4d0c523b4a8ba55c2e` | | 1994-05-03 | Supplement 17 · AP | Efficacy-New Indication | None listed | `db0326c5c143a5d4c1336a24e3e4c5f550359a8ee93b35cf47de2f0306b84f2a` | | 1994-12-06 | Supplement 21 · AP | Manufacturing (CMC)-Formulation | None listed | `8dabda9ff9e8e479b077fc51a73493f62e51cb27577281d6498c628c050d5f8f` | | 1995-02-06 | Supplement 19 · AP | Manufacturing (CMC)-Control | None listed | `6c9ed66da9f03bf6e9d47a2421ef411048243d1b53fbe9c03f2b347242c1d218` | | 1995-10-10 | Supplement 12 · AP | Manufacturing (CMC)-Control | None listed | `15d2201baad63bf688ddaae5f6768e3e70b1e91f98fb405e6dc980904ad6a754` | | 1995-11-07 | Supplement 11 · AP | Manufacturing (CMC)-Control | None listed | `2895fc9fafac9e6c865eb6f1f85bfb43be2eba3d377ade6e502417c99adaa0ff` | | 1995-12-18 | Supplement 20 · AP | Manufacturing (CMC)-Formulation | None listed | `b5c29da9797757590ec6dd211196343e5737e2da8104b691f011d8c2b67ccdec` | | 1996-02-16 | Supplement 22 · AP | Manufacturing (CMC)-Control | None listed | `9985f3825ab8b74a67d411cce9e2e3d25ac40c47e488d9eac4259da33c21b00c` | | 1996-06-12 | Supplement 23 · AP | Manufacturing (CMC) | None listed | `82e01559bf872d8db24e6be6ca00c6a8be903bf8d7b8638af8c76a6f967c2bc6` | | 1996-07-16 | Supplement 24 · AP | Manufacturing (CMC)-Control | None listed | `ddd75724741da7140ed70debba03b0a724ea747ce1b2b8f0c35ff2a0d2318bf7` | | 1996-08-14 | Supplement 25 · AP | Manufacturing (CMC)-Control | None listed | `a76d0a49c7b6737fa9b32f4d4e3b387e0026c45b22101086d1e1881265535b78` | | 1996-10-21 | Supplement 26 · AP | Manufacturing (CMC)-Control | None listed | `6609c04ad46b2577a3bdf213f5afea6fc0fa8149028a01db265444a02bc4fd93` | | 1997-10-24 | Supplement 27 · AP | Manufacturing (CMC)-Control | None listed | `a29103cb5d9e93f80ad68c91d4990312f7ce4db7805b42e8acf83d8b33b3125d` | | 1997-10-24 | Supplement 29 · AP | Manufacturing (CMC)-Control | None listed | `88923afc4b8f6c35347fb4d3159448fa823d4af0e4e9bb36ab773023d7017ced` | | 1997-10-24 | Supplement 30 · AP | Manufacturing (CMC)-Control | None listed | `7556bc4b951d22cf655e3303468d0db4ba39c746bf2664f148e99f1dbdeadbae` | | 1997-10-24 | Supplement 31 · AP | Manufacturing (CMC)-Expiration Date | None listed | `0d1332285e24cee982c9b345057ac7f018b4e94ba9ee894fe8d1709b38bf9da5` | | 1998-07-31 | Supplement 34 · AP | Manufacturing (CMC) | None listed | `bf23c5ebf13242bf5d32c24ff910260b3c223fce0703e6adda7e3b72a0c3f783` | | 1998-12-17 | Supplement 33 · AP | Manufacturing (CMC)-Control | None listed | `cf8ec85f1d0a367d78594d4d90a09ea7cb7f3d853f4278ef51126ee341f86aa8` | | 1999-02-17 | Supplement 35 · AP | Manufacturing (CMC) | None listed | `34fac4ceafc08ea3efcca6afe0346430ee08a4d2f366408dd0e2356816effe4b` | | 1999-02-17 | Supplement 36 · AP | Manufacturing (CMC) | None listed | `e2da3fd134380bb04519c0f10528d0138d0840d718b80330d67d94ce306c5cef` | | 2001-06-21 | Supplement 39 · AP | Manufacturing (CMC) | None listed | `510e36ebaa14aa6630a625273cc82854edfd55ae744bd23a54fdf65a92257dd5` | | 2001-07-02 | Supplement 38 · AP | Labeling | None listed | `3c3601206593e859485dce345fe7be16c7c9ab16d2f4af21b434f943fa5af5ce` | | 2002-01-03 | Supplement 40 · AP | Manufacturing (CMC) | None listed | `d74079da72f9b711c19e196c3613391755dd2ed6f5005168b02389fadf2c0451` | | 2002-05-13 | Supplement 41 · AP | Manufacturing (CMC) | None listed | `2fe6a43f59d2f2f0a410e40f4fab8893666592aecbc5e1f23a00ee0cb80793e5` | | 2002-05-28 | Supplement 43 · AP | Manufacturing (CMC)-Packaging | None listed | `51caa229d74957b4febb93023c86bee8603863edb017a41aa338acd0c371d965` | | 2002-07-24 | Supplement 28 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19667slr028,032ltr.pdf) | `7e5503477160317e11bee1c5913a46327d3357e557c2844118dfa62b43204d56` | | 2002-07-24 | Supplement 32 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19667slr028,032ltr.pdf) | `308c40b67f9e7e76f6743e3b3450fcf183d1eaf02b3c011c0b55f03f60a66973` | | 2003-01-17 | Supplement 44 · AP | Manufacturing (CMC) | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19667scm044ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19667scm044_Sandostatin_lbl.pdf) | `67b3242be891fb83cd2f9accfd1fd1c21babe062fdbce02ac5ae92ca6d1802b2` | | 2003-02-10 | Supplement 42 · AP | Manufacturing (CMC) | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19667scm042ltr.pdf) | `aee13abc2eb738597b5975c08ab32d5ffdedf0cd6227e9a2bccc31f3a269db1d` | | 2005-09-02 | Supplement 50 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019667s050ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019667s050lbl.pdf) | `30f649b6670bec831fc259cc5dcd7e24623ab1e36b1e6935d8895141b78708f6` | | 2008-08-26 | Supplement 54 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019653Orig1s058,19697Orig1s054ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf) | `ed4d18d9be20e8d7dbc16bb707a5c5f0acb60f2ed6ebef26969d22d43888f2d4` | | 2010-01-25 | Supplement 58 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019667s058,021008s023ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf) | `662f008ead490c9345f6aa30739f32f09e40cb0680aa247be8b24d78b0cf719a` | | 2012-03-23 | Supplement 61 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019667s061ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019667s061lbl.pdf) | `bd41c9ac9568093fb47a6bb0e534ed4ffb28818ef9aedea090703b1116fdbaa0` | | 2014-02-04 | Supplement 59 · AP | Manufacturing (CMC) | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019667Orig1s059ltr.pdf) | `f122524f0414f3efd5f1ee269b5dd2cbaf545efca97317928f3174fa9b889458` | | 2015-02-21 | Supplement 62 · AP | Labeling-Container/Carton Labels | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019667Orig1s062lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019667Orig1s062ltr.pdf) | `d6c45a53f77c99c8644a1a68b65e8241119740a3f2de9c04530c7a1bb33763df` | | 2019-04-11 | Supplement 67 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019667s067lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019667Orig1s067ltr.pdf) | `c1718ddaa0f59cdda6650319d1c5b6bdcfbc20a5c886900c32f8cd7886e14a38` | | 2021-05-25 | Supplement 70 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019667Orig1s070ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667s070lbl.pdf) | `31c4b07f237e18ef78e71fcb3fba0bf89e76262c71b44543afe1c39996dfa975` | | 2021-10-20 | Supplement 71 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019667Orig1s071ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667Orig1s071lbl.pdf) | `f72db53ead60324fa702d13bad65e55bd7ab3978ea5a93524c53ea3ef8e89a06` | | 2022-10-04 | Supplement 73 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019667Orig1s073ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019667s073lbl.pdf) | `db01aa23f5dc3494395c4eda93ea17463da0f36b4f3fa85b45d6ff8a76f08c79` | | 2023-11-03 | Supplement 76 · AP | Labeling-Package Insert, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019667Orig1s076ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019667s076lbl.pdf) | `c329fc21c50e6b3b19fec11f48e14796677afe06f37db3603b7209db617531ff` | | 2024-07-11 | Supplement 78 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019667Orig1s078ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019667s078lbl.pdf) | `9879bf0cfe83e7caa5116f68ddb1b660ebe79876677d6f6f9625666524c0a3bc` | ## NDA019732 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda019732/ - Profiles: Leuprolide - Submissions: 39; documents: 41 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1989-01-26 | Original submission 1 · AP | None listed | [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm) | `6156b5f116e952805ae33fed0638a820456b2421f78f26bc7beff6225984dcff` | | 1990-12-14 | Supplement 2 · AP | Manufacturing (CMC)-Control | None listed | `3a5df165c51e4f14114397b1d5f857b079efef43c2333af23abdffffda43101c` | | 1992-03-26 | Supplement 3 · AP | Manufacturing (CMC) | None listed | `284a7ceaba961dce7666a26ea2a77c68c48a99c254edaa365a09a049a10fca0a` | | 1994-02-14 | Supplement 7 · AP | Manufacturing (CMC)-Expiration Date | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019732_S007_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `a47e1851e6201250d6e24c2399d90c4e7e62111a519dcbfdab55900e22615bd5` | | 1994-04-26 | Supplement 6 · AP | Labeling | None listed | `c1ec99f6aba7a9b8f294f5235ee43fedc2ac33c9a4b23f42b17aa5a6dbbca724` | | 1994-11-08 | Supplement 8 · AP | Manufacturing (CMC)-Control | None listed | `b3f7beaf31ea9ba05671928e400b938609db0dd6f561f9519110f92d0851d200` | | 1995-08-11 | Supplement 11 · AP | Manufacturing (CMC)-Control | None listed | `0c8a4a36601c0105c7d31bad079b61676e915d8b1a78d6fb3d04a9cb317d91ce` | | 1995-09-22 | Supplement 10 · AP | Manufacturing (CMC) | None listed | `794179fc71fa518c05270fb695f01c86f7cd6f429ce923c2ce154fad0a19c219` | | 1995-10-26 | Supplement 9 · AP | Manufacturing (CMC)-Packaging | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019732_S009_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `de6ecc276f9dcaf9881d4e2b1dbfa1266a06c0cd57cea4e1a6d3efcb95d0a0f6` | | 1997-06-27 | Supplement 13 · AP | Manufacturing (CMC)-Control | None listed | `eac09447a353291e29b989c03a5a8cdea3be890eb96eb14f1f04c9bb5a711c4d` | | 1998-01-09 | Supplement 12 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON%20DEPOT_APPROV.PDF), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON%20DEPOT_PRNTLBL.PDF), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019732s012_lupron.html) | `42da10e548c0452d393b920cba5ec6e7c4429183db747496b7d445eacf24861e` | | 1998-06-30 | Supplement 14 · AP | Manufacturing (CMC)-Control | None listed | `0a55a1a49d67fbe55e8883e57ffa85693c041952f41ceabc97a55de99f1e59c7` | | 1999-08-13 | Supplement 16 · AP | Manufacturing (CMC) | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019732_S016_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `0eeff8c76271286ded1ed48ba1c5c64ed10816d41d141dcfe908da64c6a87ee6` | | 1999-10-04 | Supplement 15 · AP | Labeling | None listed | `e953113b0eb58b73476fceb3ad8d151ea7135e5d9a12689a7e5c6b8ea340391e` | | 2000-05-11 | Supplement 17 · AP | Manufacturing (CMC)-Control | None listed | `e6f98aad143b369e9d624792211f9240d52c0c4ad441e74c49dbdf228f317439` | | 2000-05-12 | Supplement 18 · AP | Manufacturing (CMC)-Control | None listed | `05a279929683f3fd539d899ff6f81c02222109336c7917e1aa4bff4972d13114` | | 2001-01-24 | Supplement 19 · AP | Manufacturing (CMC)-Control | None listed | `38f60a4029fece5062f4ec379cae6968357d7d9f41b6ca88e24b48a80f2eed3d` | | 2001-03-01 | Supplement 20 · AP | Labeling | None listed | `092b07382db1dec517a5e2d5169d9f9384ff53a34223e447a1c6e3d19dd009a1` | | 2002-02-21 | Supplement 21 · AP | Manufacturing (CMC)-Control | None listed | `d309a8d4e71774574226184dea9803ccecd108d84f9b9659cd0490fedbd1269c` | | 2002-05-23 | Supplement 22 · AP | Manufacturing (CMC)-Control | None listed | `5f6e688999ea305138fb3355ff0420a1f36c68f3d568d0d63be87a6af850ebb3` | | 2002-09-20 | Supplement 24 · AP | Manufacturing (CMC)-Control | None listed | `8542ba6c24607d797f430b45d1b3ee3319f7166f6ead7147b0419ab0e7ded663` | | 2003-09-09 | Supplement 23 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20517slr013,19732slr023ltr.pdf) | `8037b0870a154b243e8a90b433dc255bb6eca37d3a3136e047cf74ce4dad13e7` | | 2004-01-12 | Supplement 26 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf) | `3cc9c33f1739d444aa6c1206e8a35d1adbf94be96c428fddc63d472663e908cf` | | 2005-09-15 | Supplement 27 · AP | Manufacturing (CMC)-Control | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019732_S027_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `03f0b6ad8a1cbf49d993f88fd5313da06d12c2e8774fd57175d866fee76abe35` | | 2005-09-15 | Supplement 29 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019732_S029_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `c4735c216722e0185e6a7af8cc9f5f40c70b9c34a2aa899c7abe4e89aa30e8f6` | | 2010-04-28 | Supplement 31 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf) | `20b6c0fdda20639cedcced50afd9ac4d53023d442fc18b10afbd8f2883b94b8a` | | 2010-04-28 | Supplement 35 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf) | `2e8ee822b8734c0a4d7f73b579cc77c53914dcfdcda5672698a84d8b81957b1d` | | 2010-04-28 | Supplement 36 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf) | `eb7c01b1969d0a6df8240da6e7a5b66e177870d0656ec5e8a0bf3205af33c7b5` | | 2011-01-14 | Supplement 37 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,020517Orig1s031ltr_C.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019732s037lbl.pdf) | `c2a50aa2b2c0fd313cbe91f2bf31e55605c555a31c4a7027f66afe3be68ef85a` | | 2012-02-17 | Supplement 38 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019732s038lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019732s038ltr.pdf) | `312af1f9534162a8c3cc1dd8604a73550671430830670cdac18cb3acc254668e` | | 2013-07-10 | Supplement 40 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019732Orig1s040,020517Orig1s035,019732Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf) | `71c3cde1d9a2c0abf008b0bd98a914d5b6ffb9e56e816e48c6723c95c64e91af` | | 2014-06-27 | Supplement 41 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019732Orig1s041,020517Orig1s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf) | `6e4d9ba8893dcbf47bb94ccaea2f75e55d1ef81ba16ca0b2573c0a00754175e4` | | 2016-06-06 | Supplement 42 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019732Orig1s042,020517Orig1s038ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf) | `1f513d1e325664feb06d119d93295746a266022fc67232636322403637da7a23` | | 2018-12-10 | Supplement 43 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019732Orig1s043,%20020517Orig1s041ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019732s043lbl.pdf) | `a3b15e1bdb75c207c0ac0ea825628cf0faaaa48aa087acf7a3320f1d8985c01c` | | 2019-03-04 | Supplement 44 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020517s042,019732s044lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020517Orig1s042,019732Orig1s044ltr.pdf) | `1cf766655cf9c2cd07d2499aec84d28f8227c65efb3271d69182471ce939c052` | | 2022-04-18 | Supplement 45 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019732Orig1s045;%20020517Orig1s043Corrected_ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019732s045,020517s043lbl.pdf) | `71351aa0bbf1e7b666c012093ee99ae984425bc232b95e2370623be0d2fa1b2c` | | 2023-12-04 | Supplement 48 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019732Orig1s048;%20020517Orig1s045ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020517s045,019732s048lbl.pdf) | `2145b539fdf3a090c9b991b6015c839afc9da315b560bdabd5ef41437f268ddd` | | 2024-03-21 | Supplement 49 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019732Orig1s049ltr,%20020517Orig1s046ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019732s049,020517s046lbl.pdf) | `6cfcd9a72ca6419fe54e4e1fd883177cc6ce7f579a8c6571c61b60a729d0068e` | | 2025-08-18 | Supplement 50 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019732Orig1s050;%20020517Orig1s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019732s050,020517s047lbl.pdf) | `0a798fb66d2f8757a93ee0548fe79e5ef016ea36c0abcfd911d864ceef7e57b5` | ## NDA019943 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda019943/ - Profiles: Leuprolide - Submissions: 32; documents: 31 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1995-03-30 | Original submission 1 · AP | None listed | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019943_LupronTOC.html), [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm) | `bf962a753ced15e2d0d9879e63c619f4a814d578b660e70300a39b5b6dd3d4e0` | | 1995-08-11 | Supplement 4 · AP | Manufacturing (CMC)-Control | None listed | `8826bede90d6994156cd35d1df34921d7a5279232a181b84226a6da66d53da1c` | | 1995-09-22 | Supplement 1 · AP | Manufacturing (CMC) | None listed | `43e57628ed033ecdbc6bc1ec92c308694aa692a3ec8236b8a404bf2f49d587ff` | | 1995-10-26 | Supplement 3 · AP | Manufacturing (CMC)-Packaging | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019943_S003_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `d3867b9316356641af28bc4866b74bde6dc7c1f15638ae936e0035ce10082b20` | | 1995-12-12 | Supplement 2 · AP | Labeling | None listed | `a14bd7a7a18188c2cca7daf5b40a0443b667f9d1d114ef2c263bf3dc021a8834` | | 1996-09-12 | Supplement 6 · AP | Labeling | None listed | `ab4b9289f761b0cc898435074f65a2977dfb237028424e77675a1c6991a63be2` | | 1997-06-27 | Supplement 7 · AP | Manufacturing (CMC)-Control | None listed | `29feecb367908f5374c1a4f751a581346b917e49029ce32c280cf7c7691213ab` | | 1998-06-30 | Supplement 9 · AP | Manufacturing (CMC)-Control | None listed | `09a099276ca10f05f40cd0e3b85bf32269a35543281601962ecb05a13e32a337` | | 1999-08-13 | Supplement 10 · AP | Manufacturing (CMC) | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/019943_S010_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `6d1d1eafd3ee6c21e3a412beed0e656d449bdd45ef99ee99a60095db74abb547` | | 2000-05-11 | Supplement 11 · AP | Manufacturing (CMC)-Control | None listed | `661d4bb4ebc9697524ca72e7a2ed947509a541de3dedba4d59925cdcdea94d68` | | 2000-05-12 | Supplement 12 · AP | Manufacturing (CMC)-Control | None listed | `1e6e84415a43577ba875fa31895a2389512f9a0d7814d32e7b2787c1760f5589` | | 2001-01-24 | Supplement 13 · AP | Manufacturing (CMC)-Control | None listed | `6c59e20bab82b1d6110cb8444c73cdee48e043d9964472e20ebcd3b4da2940e8` | | 2001-03-01 | Supplement 14 · AP | Labeling | None listed | `37c5a12c8742ebd7e606bf504275999164900f50b5c076513549026a0f5eba1e` | | 2001-11-14 | Supplement 15 · AP | Labeling | None listed | `3c2a3614c26dace3eca101919493b80e43f102eaa64c0fd13cae17c8b307da3f` | | 2002-02-21 | Supplement 16 · AP | Manufacturing (CMC)-Control | None listed | `25e6484858b4bd853d3a2635c546baa052b244db2f3fdec27f2ffccc6e3647f4` | | 2002-05-23 | Supplement 17 · AP | Manufacturing (CMC)-Control | None listed | `d2fc5f93b57bcb8425f624f66a04bbe3463ba55f04eba679cdb042b127758c58` | | 2002-09-20 | Supplement 19 · AP | Manufacturing (CMC)-Control | None listed | `f19a36ccb58fc325270a9902a800034310983680f7a1dea96fd755a422c0cccc` | | 2004-01-12 | Supplement 21 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf) | `882907b5e2b9b495e1a0bf442c2cc694af0a3373acbe44917df1ef1c71c200ae` | | 2004-01-15 | Supplement 18 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf) | `08ba77bbf9c85f7c9613f28c2e5bd433f3a6d1ed4d619d4ec9592820e9dff062` | | 2005-09-15 | Supplement 22 · AP | Manufacturing (CMC)-Control | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019943_S022_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `7987a5fc4e218c879f56099dc3fd243a30ef2116f0c19f199f72509670d3d81c` | | 2005-09-15 | Supplement 24 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019943_S024_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `447edad3cdaac4bf5bc974aad92a101a0e8b617fed8f5641110b2ed3652b6dcd` | | 2007-10-31 | Supplement 26 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026,%20020011s033,%20020708s026ltr.pdf) | `47a53da274fd9659cfa246e0c5fcfddf1db4a5413f4ee01a23550a9d11da5490` | | 2009-06-02 | Supplement 29 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019943s029,020011s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf) | `b0405940a5555d336e65b4e84ecdf3a2525b75d873a2ff370bc6b9b7e71908c1` | | 2010-10-29 | Supplement 30 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019943s030,020011s037ltr.pdf) | `15334ddf29c00fec491546fc1c4acd05ac32534487a600d5c511b68fa564b83a` | | 2011-06-14 | Supplement 32 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019943s032,020011s039ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf) | `fe3e374703d7aad3a6b9a18eb76a2296561150babcddee9d2ab1439de5d66da1` | | 2012-01-23 | Supplement 33 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s033lbl.pdf) | `b774bc622ac4e99200ddd614d6d5420115125f00023b5ae34c8b11e1501cb916` | | 2012-03-28 | Supplement 31 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf) | `dd86f682167d8305f1020587ed4bf54b0eeef3c20d80cfbc6ed17785d5151c51` | | 2013-10-30 | Supplement 34 · AP | Labeling-Patient Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019943s034lbl.pdf) | `a7c215c147ffc3d94cde212b3765a5ed61f34594bf4928bd8e3d855d89c161f9` | | 2021-02-12 | Supplement 35 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019943Orig1s035;%20020011Orig1s042ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020011s042,019943s035lbl.pdf) | `ab8645862b0912a8691921470812e661b20ae8537b556437f5828936e5360c68` | | 2023-01-27 | Supplement 39 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020011Orig1s046;019943Orig1s039ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020011Orig1s046;019943Orig1s039lbl.pdf) | `e0bdf9c37e210686a5474b3296730d9da09ce263d7afb9802c06d6da79d78a89` | | 2025-09-10 | Supplement 40 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019943Orig1s040,s041;020011Orig1s047,s048ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019943s040s041,020011s047s048lbl.pdf) | `7fc4b0368090dad207ed0e0ba265ccbf53e617c41d9ea3c2bc8fec067e516391` | | 2025-09-10 | Supplement 41 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019943Orig1s040,s041;020011Orig1s047,s048ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019943s040s041,020011s047s048lbl.pdf) | `f4bfe047d8c5f00a1fe0e8821d43f187cc095decabd5c879c957bb1ccfafbce6` | ## NDA020011 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda020011/ - Profiles: Leuprolide - Submissions: 37; documents: 31 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1990-10-22 | Original submission 1 · AP | None listed | [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm) | `8ec58e9e61c80c4b8a6b72c4316465b48981bb32a85422f71a52c81abbbeae78` | | 1994-02-14 | Supplement 3 · AP | Manufacturing (CMC)-Expiration Date | None listed | `d82af523508f331cb60b264ac09d4b2e8419dfd15d2794118c4749943b6b71c3` | | 1994-04-26 | Supplement 2 · AP | Labeling | None listed | `3a855cdd0efe865e0c31366f329849d4013e368f7227f7645a36bee006a567a2` | | 1994-07-21 | Supplement 5 · AP | Labeling | None listed | `7a8fe88d8501c92dfd2aab3a8aae222d492c1e83f03650dfc21721bb1353b2d9` | | 1994-11-07 | Supplement 4 · AP | Manufacturing (CMC)-Control | None listed | `b292e8684164cca07ae38d12d0e65fe9ffc9b0bf086557274d7e7b97368832c8` | | 1995-08-11 | Supplement 8 · AP | Manufacturing (CMC)-Control | None listed | `810e1743ea5e7059e513c51dfa74ac4490c00c3d06baa013530fc0f9ead5fb74` | | 1995-09-22 | Supplement 7 · AP | Manufacturing (CMC) | None listed | `44a8b4c51a19d203d1c4667c718e25e99ae3954c9ae1472bc4a571fa3b95fde5` | | 1995-10-26 | Supplement 6 · AP | Manufacturing (CMC)-Packaging | None listed | `8b07c6c84ad605797cc1aae2245212d7a47ff4f31eb2a729340f4ad44839e2da` | | 1996-09-12 | Supplement 10 · AP | Labeling | None listed | `cd0af99681150242f7f215ad2ba189d0d3e8c53e42581bb2af148ccd81d7dba3` | | 1997-06-27 | Supplement 11 · AP | Manufacturing (CMC)-Control | None listed | `034c8bb5857bcb25da1513e49191b814a203ca0c0b928003e65953bd241dd1e8` | | 1998-04-09 | Supplement 14 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-S014_LUPRON_APPROV.PDF), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-s014_Lupron.html) | `4c6678a003ca38a90ef6141751f3168d0432c8ceca2869a7d32cd4d0f717d85a` | | 1998-06-30 | Supplement 15 · AP | Manufacturing (CMC)-Control | None listed | `04ac4c488ec2dcf5d67c58abb4d9ee326b4ec7fcb5ae769f81b9f38870001025` | | 1999-08-13 | Supplement 16 · AP | Manufacturing (CMC) | None listed | `1464875958c7604f3c4fae7819137ae7a01702b6ba3efbd2d6e784b744a52c7d` | | 2000-05-11 | Supplement 17 · AP | Manufacturing (CMC)-Control | None listed | `a66ce705871f006ef16cfd7defa7ca595282cfea9420c4d43c3694737344bec5` | | 2000-05-12 | Supplement 18 · AP | Manufacturing (CMC)-Control | None listed | `cb938bd22a6b741972f565a49f5701866eccddbac29aeec491dbff62af6e8a4a` | | 2001-01-24 | Supplement 19 · AP | Manufacturing (CMC)-Control | None listed | `32e0b709eb10dbbbe0e23812ce19b8f304f16d926f226e2e8cb43519b7b91261` | | 2001-03-01 | Supplement 20 · AP | Labeling | None listed | `ccb9b61c5cfc39cf6b31db2afa3d38c30905edfe99be6e6c43122e16fa424362` | | 2001-09-21 | Supplement 21 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20011s21ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20011s21lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-011S021_Lupron.html) | `c3e2e28a7655849985849656444d077020c27039b0adb295e6a0d9bb9f7ab23f` | | 2001-11-14 | Supplement 22 · AP | Labeling | None listed | `a4b50a30095a6baa7044102a095e6c75090c4363d00b39b749e9bb091c0c8bbf` | | 2002-02-21 | Supplement 23 · AP | Manufacturing (CMC)-Control | None listed | `a27adbf28e6531411c6d8539170db432f380b37423095e5f5b5911220cbd1417` | | 2002-05-23 | Supplement 24 · AP | Manufacturing (CMC)-Control | None listed | `81fda1249f3f71bde8cb238d78b6e111bf92114de91986c218ba4da092ede8cc` | | 2002-09-20 | Supplement 26 · AP | Manufacturing (CMC)-Control | None listed | `0cce4a65f3fd1305f21f1a6900de5059edd8a500bda9031d4d1344fa549b8b01` | | 2004-01-12 | Supplement 28 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf) | `a66a003eb0c9e5802f5ecaf058c9803d85d7b7338f5ea610cca83b0c0b0e9fde` | | 2004-01-15 | Supplement 25 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf) | `9310e05ae51309c11d84eeb88ef9c51f1aba4296d2bb5a14dbaf7bc60fe4109a` | | 2005-09-15 | Supplement 29 · AP | Manufacturing (CMC)-Control | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf) | `f774cb45d6a8054b691cadc5434d73b74bc227504be22f0dc2f043ecb0c1ca4c` | | 2005-09-15 | Supplement 31 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf) | `b9aa6c6292e15270388208a89c8f8f7d8c3d55e4a8d6219fb5bccd191f36cb68` | | 2007-10-31 | Supplement 33 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026,%20020011s033,%20020708s026ltr.pdf) | `5892e0f4a25c54640683370d940a7346fe376fc4556d4bd5e384451b485e5760` | | 2009-06-02 | Supplement 36 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019943s029,020011s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf) | `f274fef1c4ac42685b2dcb261126e10362568ebd2b04632db4a7e7862bf24bcf` | | 2010-10-29 | Supplement 37 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019943s030,020011s037ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf) | `133e3c87544cb0b22e5ccc7158da1da36fb24b7387c93f94b69b945a64de6582` | | 2011-06-14 | Supplement 39 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019943s032,020011s039ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf) | `128eff9cec67fb4279a9820b5bd29afb42f0ecad76123020d58ce76fc3a29fe1` | | 2012-01-23 | Supplement 40 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020011s040lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040ltr.pdf) | `aad9d53196bcde368b043676bb64261e2e69cc710a97ef64eab6d4b843641632` | | 2012-03-28 | Supplement 38 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf) | `fbf16b7749bcaed179a5b52884f6ffc57200fa06b39b67f6864b0abce1ab44b2` | | 2013-10-30 | Supplement 41 · AP | Labeling-Patient Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020011s041lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf) | `32ec9ef0dd7c4365d9832051f69204eabef2cc2ee2631b003221ed6babfe9d66` | | 2021-02-12 | Supplement 42 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019943Orig1s035;%20020011Orig1s042ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020011s042,019943s035lbl.pdf) | `ec575d8c2223c96dc39b9beb93f0a4be1bccc13acaa376851d84bf4dfd835c94` | | 2023-01-27 | Supplement 46 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020011Orig1s046;019943Orig1s039ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020011Orig1s046;019943Orig1s039lbl.pdf) | `c3aa6cbaf6693a0ee08b7136ef2bce5f0c658e62f8598f5523b9645ada1beda5` | | 2025-09-10 | Supplement 47 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019943Orig1s040,s041;020011Orig1s047,s048ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019943s040s041,020011s047s048lbl.pdf) | `0a43aed5eab89b9f83f8ed96b388611aec5754d08f92950ac32c84fddca3e65d` | | 2025-09-10 | Supplement 48 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019943Orig1s040,s041;020011Orig1s047,s048ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019943s040s041,020011s047s048lbl.pdf) | `38bd58b8dc3e375b6c6d26b72dfd9268a32238c7148d590567dcd84ce32b0528` | ## NDA020263 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda020263/ - Profiles: Leuprolide - Submissions: 41; documents: 48 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1993-04-16 | Original submission 1 · AP | None listed | [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm) | `7bccfbe25a6b2131ede9393111a71a63ebc99567a4e06fd26e641222448e9830` | | 1994-01-21 | Supplement 1 · AP | Manufacturing (CMC)-Control | None listed | `8ffd94f332c54b955948b8e895766e8b3e7be2a9c2dbbc823d9af81d62f7ede6` | | 1994-02-14 | Supplement 3 · AP | Manufacturing (CMC)-Expiration Date | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S003_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `acdefd92ceb8a978b4787f202f1b2daf4f34ea7b04e65efca552424e2ad26ade` | | 1994-11-07 | Supplement 4 · AP | Manufacturing (CMC)-Control | None listed | `e4f505dab53de3352e2782df12a4a1f0bde05a78237651007c108493ffc8aa7c` | | 1995-03-24 | Supplement 5 · AP | Labeling | None listed | `49c3d18ac807b3587ad20ce40187db65d4df28532d8e929e6c6b1b2b470224e8` | | 1995-08-11 | Supplement 8 · AP | Manufacturing (CMC)-Control | None listed | `9fe627e49b3008ea35d11e67d924e95c6f8ca3a5391c1bf2fdeee01fb477f30c` | | 1995-09-22 | Supplement 7 · AP | Manufacturing (CMC) | None listed | `63d4b2f4fcf12b100abcf593e1b03bdad530e3c3ffe24f67d75ff6aab0698d27` | | 1995-10-26 | Supplement 6 · AP | Manufacturing (CMC)-Packaging | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S006_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `37b054202ed301b4f52d4133acc47065cee851775caaeddb12924f049dc1420b` | | 1997-01-10 | Supplement 9 · AP | Labeling | None listed | `3f61e59e0cbf356ef51e5f0421b7cb979300d7ff7c7b9f525ff5132b3bf449bf` | | 1997-06-27 | Supplement 10 · AP | Manufacturing (CMC)-Control | None listed | `d1032ae04193e7224ab71051aee6a549d3d6fc5da332e9661f5b37f8cf3c5a1d` | | 1998-06-30 | Supplement 11 · AP | Manufacturing (CMC)-Control | None listed | `242b091f3bc1baef3f307e0cee345a75ea2fd9e5ccff881a0bbee91c0e7b353a` | | 1999-08-13 | Supplement 12 · AP | Manufacturing (CMC) | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020263_S012_Lupron%20Depot_APPROVAL_PACKAGE.pdf) | `5dd46fc5658dc2d87f71deaa7b87c97de64575bf04a9dd42282aa78459f75070` | | 2000-05-11 | Supplement 13 · AP | Manufacturing (CMC)-Control | None listed | `45b9697226ecba777eb461054fb7c040743e996e78d5398dd045ebe979d6809b` | | 2000-05-12 | Supplement 14 · AP | Manufacturing (CMC)-Control | None listed | `122f0d6087d1383526d9acd344939c6bb46b1bc7f5748ec2cf3bd6235b47b123` | | 2001-01-26 | Supplement 15 · AP | Manufacturing (CMC)-Control | None listed | `9e17238a48333419d73fc4a1d1b837baafaa0fa4216b96c8b986eb4e85119e28` | | 2001-08-06 | Supplement 17 · AP | Labeling | None listed | `8009265d047270fa7cc0d7118983d07bb96786d05f3861a8f8bea187fa08b2f1` | | 2002-03-08 | Supplement 18 · AP | Manufacturing (CMC)-Control | None listed | `ff87732bc7f3a1741e763d025ea5fe66e8bc7323814a04b759f33a04f9cf6aec` | | 2002-05-16 | Supplement 19 · AP | Manufacturing (CMC)-Control | None listed | `e95aea572515851ac5c92e4d6848949611e330475979857de82eef04ad92c34d` | | 2002-09-24 | Supplement 20 · AP | Manufacturing (CMC)-Control | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20263scs020ltr.pdf) | `4c8370ec82eea99dedd60108f9f15f4c4dfc40fea128e7db0c38ce4e8547973e` | | 2003-10-28 | Supplement 22 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr022ltr.pdf) | `5a548834d9f163b7b8504537dbc7a045fc71e053c8e5161f3fbb075bcf60f7df` | | 2003-12-23 | Supplement 23 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr023ltr.pdf) | `0224dd9b0265d73348b9597ac033c63dff2317c6440f19ed3948ccdaaedff84e` | | 2004-03-02 | Supplement 24 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20263slr024ltr.pdf) | `64950217ee8088490d3394250b74e6c124aca04254c8c4db1cdf27b22230f13e` | | 2005-11-09 | Supplement 26 · AP | Manufacturing (CMC)-Control | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020263s026ltr.pdf) | `06952ab3e77835aaaba1d3a40050f74a63b9878cd618c62a507e1c274e2ec17d` | | 2006-02-16 | Supplement 28 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020263s028ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020263s028lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020263_S028_Lupron%20Depot%20Ped_APPROVAL%20PACKAGE.pdf) | `aa42a93db21ca34e3fc29828706135b87464578ff9baec288c722b62b74c1859` | | 2008-07-31 | Supplement 30 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020263s030ltr.pdf) | `4d74a8f89b887cac8ba6c2469955c1e54592fbfeed179c60f32b1b138a78f480` | | 2009-06-24 | Supplement 33 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020263s033ltr.pdf) | `1d4b65ef892098964b5ebae88e2c53b15a3254cb7b4b52bf4bf78e21bc648fe5` | | 2010-08-30 | Supplement 35 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020263s035ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020263s035lbl.pdf) | `aecc7a6ddbf6cd078f89eb773917afd7683ca9dd87d26300fd59885ed53be5c6` | | 2011-08-15 | Supplement 36 · AP | Efficacy-New Dosing Regimen | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s036lbl.pdf) | `2a86db93e7817b7fb32e7eefae32b22bdb28ce806c87f09a7479c49e8a2c694b` | | 2011-10-08 | Supplement 37 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s037ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s037lbl.pdf) | `405a77746ccec6859b6cf9a3c76381ca38f74ca7495841e98873bb8fda8cf728` | | 2013-05-14 | Supplement 39 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020263Orig1s039ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020263s039lbl.pdf) | `1c17a1a7c6fb6bd7e3ce5e781f23929660f1812c3a995b8814fca08f0ef34cd4` | | 2017-05-19 | Supplement 42 · AP | Labeling-Package Insert, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020263Orig1s042ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/020263Orig1s042.pdf) | `a05364cb1cb3db5ea73851e1e9fdc29a74ceee10d1d17e8bd3b75874efabc1cb` | | 2020-04-07 | Supplement 46 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020263Orig1s046ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020263s046lbl.pdf) | `2300eea0eb5f67ff25e35272028de378c9f02f11b9aa9f75bd4366f63dd2afab` | | 2021-03-11 | Supplement 44 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020263Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020263s044s047lbl.pdf) | `dba8c5c518597e1882935a7e7d691b3e9a02a4abf4215a96170cb2229d398efc` | | 2021-03-11 | Supplement 47 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020263Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020263s044s047lbl.pdf) | `cdafe6a53128068e7e5e04343590e1d3b5b37d328d37655613d411c710a5c59f` | | 2021-11-12 | Supplement 48 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020263Orig1s048ltr.pdf) | `23b662aa5636730bc1f3cb7ea8728190253d75b21c389dc649caf2b2c01d277e` | | 2022-04-22 | Supplement 50 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020263Orig1s050ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020263s050lbl.pdf) | `42f36b9ab313363b40ba499a78e02aaf6fbc65a3088ddd4ed748f41f3732eb3d` | | 2023-04-14 | Supplement 53 · AP | Efficacy-New Dosing Regimen | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020263s053lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020263Orig1s053ltr.pdf) | `ba33ed8e8cacf5d2392d31c1aaba0b04251f934e9328ace14c7fb2924aac84da` | | 2023-12-04 | Supplement 54 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020263Orig1s054ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020263Orig1s054lbl.pdf) | `2fffd51f8d81c763c5f74abf288f1c3e4fdb98d637f459523411423deeaf493e` | | 2025-05-22 | Supplement 56 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020263Orig1s056ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020263s056lbl.pdf) | `d878d627df185fc9b672e85b1c2bc4223fe8f58c6d263a615ed763ce39378af1` | | 2025-09-23 | Supplement 58 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020263Orig1s058ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020263s058lbl.pdf) | `47efd6b86216296da781b13e5a0a47a08be8f1cc1f8bd5901fd9620c7ddde885` | | 2025-11-14 | Supplement 57 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020263s057lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020263s057lbl.pdf#page=26), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020263Orig1s057ltr.pdf) | `b801813ac2dacd9da3afda7e8de14f1c29b0180a301e6366280bbc77361b1cc9` | ## NDA020517 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda020517/ - Profiles: Leuprolide - Submissions: 36; documents: 48 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1995-12-22 | Original submission 1 · AP | None listed | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020517_S000_Lupron_Depot.PDF), [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm) | `5a07c389c38ba3a72aca7a0355c7b42fef42110c5579c83401899b0a997dcea3` | | 1996-12-03 | Supplement 1 · AP | Manufacturing (CMC)-Packaging | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20517S001_Lupron.pdf) | `a7770bfc68ca9e51e27fa866ff9613e7cd85da6dacaa1d4a5d8d6d04591bd900` | | 1997-05-30 | Supplement 2 · AP | Efficacy-New Dosing Regimen | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020517_s002ap.pdf) | `e89659cd9f6d0adb43e028ebe881acc3b94a2ca4aa3401c7ce60b40219a773a1` | | 1997-12-23 | Supplement 4 · AP | Manufacturing (CMC)-Control | None listed | `1ac44119042c7f6ca79beebbc3da8274aaaee0b5cc251d9cb359ac55b45b18bc` | | 1998-07-29 | Supplement 5 · AP | Manufacturing (CMC)-Control | None listed | `5c12e05d51b43dfb569fedfecef2d8ac6949bee89125609f1429c84d1ee1faee` | | 1999-08-13 | Supplement 6 · AP | Manufacturing (CMC) | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020517_S006_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `6366cf8060b2246174984cec0a57746067c9ae5b880a37f2707ce7d44f4b63a2` | | 2000-05-11 | Supplement 7 · AP | Manufacturing (CMC)-Control | None listed | `0bb31702eac811a4ad87bf06f42d8b2d3cafb86403d4abd3fa806efb7e8c9fe5` | | 2000-05-12 | Supplement 8 · AP | Manufacturing (CMC)-Control | None listed | `3703c7f312c044fd4bab5a0b2540aca74c949bfee5d2f167a45c969b9d86febe` | | 2001-01-24 | Supplement 9 · AP | Manufacturing (CMC)-Control | None listed | `bce8f4e473926a1160f3687a0cfce7992827aa2dd41988b65e8a22f8aa264fcf` | | 2001-03-01 | Supplement 10 · AP | Labeling | None listed | `0b0bec23e3a6b59a3064c8308baddf466f013dd5e44351de740c3d2b6ad25347` | | 2001-07-23 | Supplement 11 · AP | Manufacturing (CMC)-Control | None listed | `9b28ec1805ac69b81e1a0b33291079106be6f6eab8d1c96f3d929fd9035df680` | | 2002-05-23 | Supplement 12 · AP | Manufacturing (CMC)-Control | None listed | `a69a471f336652d49367d95a3600a20e66d108c76de514cd385d2d6285c185b2` | | 2002-09-20 | Supplement 14 · AP | Manufacturing (CMC)-Control | None listed | `b461bb70b6c1a4c1304ac19b0c1268178cffb6d9732391d188b7e0bd5e25593d` | | 2003-09-09 | Supplement 13 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20517slr013,19732slr023ltr.pdf) | `c3a554b43587c454ca6088b44eb9af2fa6a94fb63fe686ecbded3055a69ad3bb` | | 2004-01-12 | Supplement 16 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf) | `2e3f34c19b8f3d6f6aa8e2d909b2ab87cde67bce415a0af2fce9195ca7c7548d` | | 2005-09-15 | Supplement 18 · AP | Manufacturing (CMC)-Control | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020517_S018_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `3dd8a030a6ca59ac1a9c45a4bcd76eeccb74c635e3eec5bb72c2b784a35808dd` | | 2005-09-15 | Supplement 19 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020517_S019_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `09097d5ca99d542581c999ac03d0f54704ac9ed853e3db38d9de93dda97bd1aa` | | 2010-04-28 | Supplement 24 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf) | `f4ca8824150f6dcd7db70dcdc885f0d2cfcf9efa113b090d1f5c2ba5be595ffd` | | 2010-04-28 | Supplement 28 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf) | `ad40ebb95312004a226f7c87d52bee68449175c08c046c3891c3fc13338a5405` | | 2010-04-28 | Supplement 29 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf) | `08557859849c7cee056957f68e2fd5fd8808ebd7f1da80b95bd29db8e854274a` | | 2011-01-14 | Supplement 31 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s031lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,020517Orig1s031ltr_C.pdf) | `860f1f5f7330f2e2a8ece8c2bbe2d5c65718d7b5ac025fe67cbf54578510ba1c` | | 2011-06-17 | Supplement 25 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf) | `61b6d904fced69d239651b1862a4350dc39ff5aa1d1747a2aaf0951bfdc6058e` | | 2011-06-17 | Supplement 30 · AP | Efficacy-New Dosing Regimen | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf) | `d3c3f7729adc204de556f806d1f0a71de01adf63b7944b8ad4aa94c1a050a18b` | | 2011-06-17 | Supplement 32 · AP | Labeling, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf) | `8201d17b6ad74417cecafb4bf394825e9ca04c851bf72c2cc62f3ff6d713bb9a` | | 2012-07-18 | Supplement 33 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020517Origs033ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020517s033lbl.pdf) | `92cd8101ab4283ff7d2b123121f702cd0500a12af82b538e69ccb79dda382203` | | 2013-07-10 | Supplement 35 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019732Orig1s040,020517Orig1s035,019732Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf) | `98da72007803f1465d11d53a2f1778dd614543236c6f03f7db9f515b55b41c49` | | 2013-11-08 | Supplement 34 · AP | Manufacturing (CMC) | None listed | `ad5db6927f2f5933091b4994ade55318efb3b57fe0985069be460a537cb1d375` | | 2014-06-27 | Supplement 36 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019732Orig1s041,020517Orig1s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf) | `83b9d0fc6b5712601d1c9bbc79ffa504ab57599b3c66737303de72b5da95148c` | | 2016-02-11 | Supplement 37 · AP | Manufacturing (CMC) | None listed | `e37fda7da71ca174d9ec67b947c065d0eda513fba06d4a38a4292d6bca7a4f9d` | | 2016-06-06 | Supplement 38 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019732Orig1s042,020517Orig1s038ltr.pdf) | `62990509d6243e454dde227aa05d3dff5841b5c50cc9db5f87143c6d5d5ba547` | | 2018-12-10 | Supplement 41 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019732Orig1s043,%20020517Orig1s041ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020517s041lbl.pdf) | `1ba58bd3de80dc385d91f9677a6e6b292f77c32f18080bd8be41e2a8598ab3c2` | | 2019-03-04 | Supplement 42 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020517s042,019732s044lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020517Orig1s042,019732Orig1s044ltr.pdf) | `dc5b439b6dcb9fc541007d0a3e998a48a0efae5f0eed83c11f0cd3c03b2e8057` | | 2022-04-18 | Supplement 43 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019732Orig1s045;%20020517Orig1s043Corrected_ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019732s045,020517s043lbl.pdf) | `20d3477b24a307d8a3833829dfd9140dae3a154f7b77b7b93773028f5d5015d0` | | 2023-12-04 | Supplement 45 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020517s045lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019732Orig1s048;%20020517Orig1s045ltr.pdf) | `10343a9134c0e757fbd2975d6933df98ae8df1cb765254ae6a777b6e75c1f3b0` | | 2024-03-21 | Supplement 46 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019732Orig1s049ltr,%20020517Orig1s046ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019732s049,020517s046lbl.pdf) | `9b97510b6405a502c6f9e91180ca6571e995b99c01626f70f632a244b6a7cabc` | | 2025-08-18 | Supplement 47 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019732Orig1s050;%20020517Orig1s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019732s050,020517s047lbl.pdf) | `a451a4d4d4e0e3452e3ef1d9cd85fb43bcff2df228b3e676cd2063233eeea0bc` | ## NDA020708 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda020708/ - Profiles: Leuprolide - Submissions: 31; documents: 37 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1997-03-07 | Original submission 1 · AP | None listed | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020708_lupron_toc.html), [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm) | `6b023c5344dd859ed0c498001e1ec37251f035f9943ae48c3b1a204092ce29ee` | | 1997-09-04 | Supplement 1 · AP | Labeling | None listed | `2f7b8b998383d3bd60c1f7e62614574e3c40bc1cb605106237db16be39a2a241` | | 1997-12-23 | Supplement 2 · AP | Manufacturing (CMC)-Control | None listed | `33e799da58a63fce84b8d763a81d4009177e426c7b96c0da5c26622597cfe19d` | | 1998-04-09 | Supplement 3 · AP | Labeling | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-s014_Lupron.html), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-S014_LUPRON_APPROV.PDF) | `3336bae949e982205999036b0e4d3574b14f4bcb45f8f8d4d8092974c4f3e3b7` | | 1998-07-29 | Supplement 4 · AP | Manufacturing (CMC)-Control | None listed | `df193664e57f5726a266d813d149f03f209a57d9e5d9d0a19b4934c948fbc9a3` | | 1999-02-11 | Supplement 5 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5_appltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5.html) | `27ba377d48a4632d7b5214bea959bc75585b0ca85e8eb99d57e15e70ec5bb019` | | 1999-08-13 | Supplement 6 · AP | Manufacturing (CMC) | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020708_S006_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `bed46c3892997833f0ab111b788c1e8c5f135b7c3ff8ce7917d3409dc44ee37c` | | 2000-05-11 | Supplement 7 · AP | Manufacturing (CMC)-Control | None listed | `e8218068efcd74e63724fe2c918709a6243c9fcbc9543c598b58b0bdc6df16ce` | | 2000-05-12 | Supplement 8 · AP | Manufacturing (CMC)-Control | None listed | `5bdcd84811a06a6ce4845b707c5c9fc7e1ac06f381cbdc671b053d8e0576ffb8` | | 2001-01-24 | Supplement 9 · AP | Manufacturing (CMC)-Control | None listed | `5462da525636d55d10d1a222d0e6b541ba78ca2f750d64c72478b2da86ae5402` | | 2001-03-01 | Supplement 10 · AP | Labeling | None listed | `4e3b78f9dcecfd90d0161402704eef3133ba1ba2c0e41d502966b770b37ef7b6` | | 2001-07-23 | Supplement 12 · AP | Manufacturing (CMC)-Control | None listed | `12a0a7386c1740d7a84630dab1bf7bb8c6da1bddd0515e9b683dd18784ac5a58` | | 2001-09-21 | Supplement 11 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20708s11ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron_prntlbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron.html) | `5abaf5e3139cef16b3e196caa6b597192f3c0cb6e41647e76f327236a6a0122a` | | 2001-11-14 | Supplement 13 · AP | Labeling | None listed | `1290e58461b2be1f5e77e31b5799b0f6c23cb44c8749c9d327ef080893a8f0fa` | | 2002-05-23 | Supplement 14 · AP | Manufacturing (CMC)-Control | None listed | `05359c535b837970d4dd1f33eba3b3f13478ed544468eb1fe91c731a8952c185` | | 2002-09-20 | Supplement 16 · AP | Manufacturing (CMC)-Control | None listed | `7bb6611e46eb4edadfd768706a009d28d067bddfe5ed0ae292a48e25b7854c86` | | 2004-01-12 | Supplement 18 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf) | `8ff42d3f40be6f883f7d180f47941f39006caeba9ced6fe51f71c0b6706e9b83` | | 2004-01-15 | Supplement 15 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf) | `1bc019766575ca7f1c4d6732fe6e209b2a5abd69061ae14316d7686f173deb18` | | 2005-09-15 | Supplement 20 · AP | Manufacturing (CMC)-Control | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020708_S020_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `458dfc52c59bf214a15f87a5538ce804982c96d128eaec44c67389d0c504d7f7` | | 2005-09-15 | Supplement 21 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020708_S021_Lupron%20Depot_APPROVAL%20PACKAGE.pdf) | `cf0e27ce5bf85dc722c1dd362e6f75a3545c2d2e8f48f8dccd3f5a1880ea537e` | | 2007-10-31 | Supplement 26 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026,%20020011s033,%20020708s026ltr.pdf) | `f0ab5de50c6a8090de0f52dead49baef299d726db1d105487de67d06f39b1e72` | | 2009-06-02 | Supplement 29 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020708s029ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020708s029lbl.pdf) | `820cf5bf40950a3f15fd8899de5461b154af00c08ad2500c60d01f3ada3d2c37` | | 2010-10-29 | Supplement 30 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020708s030ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020708s030lbl.pdf) | `5704df3ed52fbeaed5488277703fcb8d3b98dc3c4d9ffa5f20184a3668402a42` | | 2011-06-14 | Supplement 32 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020708s032ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020708s032lbl.pdf) | `c7f453f4308ae7ab3c3e771261872288b43ff03cb6a3bc5964b1cb4df941dbe0` | | 2012-01-23 | Supplement 33 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s033ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020708s033lbl.pdf) | `c7f5d88d34fe6ed972aae3132fbf09e9b0f4990c1430add51a3be5c5555b8ef7` | | 2012-03-28 | Supplement 31 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf) | `eaf057b672cd1ab1b04d13e1855d241070f000b7a64c8f1ec133f939f7691319` | | 2013-10-30 | Supplement 34 · AP | Labeling-Patient Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020708s034lbl.pdf) | `a21e12002b2854c3c7b0984b818f8c66f87ca78410bb7ef5600b207948f92421` | | 2018-04-18 | Supplement 35 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020708s035lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020708Orig1s035ltr.pdf) | `5f330b6fb6bbb066349a4ee1f5388fec92544d4384ebfc6f9f13475a812c0b06` | | 2020-03-18 | Supplement 38 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020708s038lblrpl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020708Orig1s038ltr.pdf) | `1eb8c6f6e4fd486e36cc42f11b009efbb2a766a050e9e58ca36e19e56b67644a` | | 2025-09-10 | Supplement 40 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020708Orig1s040,s041ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020708s040s041lbl.pdf) | `a709e41576678644ba61c4a3f3ea76d903427dcb8bd5a847339840c402aff5bb` | | 2025-09-10 | Supplement 41 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020708Orig1s040,s041ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020708s040s041lbl.pdf) | `b0d42b49ed0ef7fe0e36eb555747e9c095abf7b45b767fc6b303ee117facdc57` | ## NDA020918 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda020918/ - Profiles: Glucagon - Submissions: 24; documents: 28 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1998-06-22 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20918lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20918_ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020918s000_GlucagenTOC.html) | `e9972cee540fdc54fef8a7674977540e763cb6007a01fb5162b9eea4ad6bc14c` | | 2000-05-30 | Supplement 1 · AP | Labeling | None listed | `1717970aef38b40aff216272b7ffb57e58f7b49e150aade2e0d0e9dede68d459` | | 2000-08-18 | Supplement 2 · AP | Labeling | None listed | `33bacd69a46e72ac32b55b6691232108ef30b634b5edd860afcbc4b02afd46ac` | | 2002-04-01 | Supplement 4 · AP | Manufacturing (CMC)-Control | None listed | `d158e5c6f2147a9daa250fbda66c3847a746805ea5dfaef61cf33ddda7668786` | | 2002-07-11 | Supplement 3 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20918slr003ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020918_S003_GLUCAGEN.pdf) | `9c0e4649fe606153256695ffa36f42d0f5cf6343fe1ead8e42532c52ea29e167` | | 2002-08-05 | Supplement 5 · AP | Manufacturing (CMC)-Control | None listed | `cc725021e247a822a176d5e34aa396986f827d5d4704e36e22985532a60e5412` | | 2004-03-01 | Supplement 8 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918slr008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918slr008_glucagen_lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020918_S008_GLUCAGEN.pdf) | `8af54d8b4e19c747b6ba20f5ae52c359c5b536b68dec45522665460b3fb3cb91` | | 2004-12-23 | Supplement 12 · AP | Manufacturing (CMC)-Packaging | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918s012ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918s012lbl.pdf) | `9d0499152165cabea8d03d6bcb15a0b0b2347bf6640a348823de9e0c31b5b91e` | | 2005-11-14 | Supplement 17 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020918s017ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020918s017lbl.pdf) | `da526701f7b58bcb758d0920fc7327caf2c9df0eae9550611db2950f9957c112` | | 2007-06-28 | Supplement 23 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | None listed | `1514fabeb0ec5b283bea448a1dd7d6cb3d91cffd9620038415e2643a5c9d91ed` | | 2010-12-15 | Supplement 30 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020918s030ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020918s030lbl.pdf) | `edb9ab0a05fcbd359f854071cde19cb91679967fc27b5e8d6d4a6a59ba93b63f` | | 2011-12-29 | Supplement 34 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020918s034lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020918s034ltr.pdf) | `58577e1324f3fdf3372ca4766a860bd81d9e9b9b7eeb162ea86bef743f7b426f` | | 2013-01-16 | Supplement 38 · AP | Manufacturing (CMC) | None listed | `a3883dae84cb5e0501bf83385fc70719585d3f3fae369538ef956e6330c302d4` | | 2013-04-26 | Supplement 39 · AP | Manufacturing (CMC) | None listed | `a14188881ce1429405c8afdb606473ea07265d6061205c5ecbb8efbd071c4f81` | | 2013-04-26 | Supplement 40 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020918Orig1s040ltr.pdf) | `c7f56ffe97e88114c2fdefc7304295f88c97a8f2530fc3bdbafde94469c4e535` | | 2014-03-14 | Supplement 42 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020918Orig1s042ltr.pdf) | `1a06fda4338cee0523c91720548fb9511ee09a801af97bba145e1a853e2b3af4` | | 2015-10-08 | Supplement 44 · AP | Manufacturing (CMC) | None listed | `1042f5c98d207fc84da34311f330e0c50a85d392d873c289b3fb544b76687ad0` | | 2015-12-10 | Supplement 43 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020918Orig1s043ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020918s043lbl.pdf) | `23881d7e9fec153cde55f18582e6a031fda9f5281218227e4d7744b89cbdbf4b` | | 2016-02-11 | Supplement 47 · AP | Manufacturing (CMC) | None listed | `20fcc419154964c96b444776437d74e723a4e5238a34b9d93fc2beaef2490657` | | 2018-04-18 | Supplement 49 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s049lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020918Orig1s049ltr.pdf) | `ccc080ce73097622c1b6ad3b5691ce2ba6826a5a89f2603813bd0d68ce7adcac` | | 2018-07-06 | Supplement 52 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s052lbl.pdf) | `c8e13291e90727440889884ad539dd44890bf375675583d1059fc6c92cc680d6` | | 2020-09-03 | Supplement 53 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020918Orig1s053ltr.pdf) | `900bd3987960286bcb5b60ded0254dafa49647dc336a5ae3eb236ef8c9164f87` | | 2021-03-11 | Supplement 54 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020918Orig1s054ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020918Orig1s054lbl.pdf) | `55697023a4d6fde394a6fd71e4e5af92e18161d5540979ef2badcb0a6a0ff046` | | 2021-07-20 | Supplement 56 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020918Orig1s056ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020918s056lbl.pdf) | `e7f13124a68567ad122f15faaf48294c334b6c9e4db5a932c26e47e52ca7618b` | ## NDA020928 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda020928/ - Profiles: Glucagon - Submissions: 16; documents: 12 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1998-09-11 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20928lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20928ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20928.pdf) | `71170b6d5266b66a5902398da94106bfb6db1d28c5458366a848df5d7baff93d` | | 1999-07-19 | Supplement 1 · AP | Labeling | None listed | `6a6e7617029cbce1c0f5a2764a8f72d642be0e710b997edc978d92ab12f22d10` | | 2001-09-13 | Supplement 2 · AP | Manufacturing (CMC)-Control | None listed | `223f341f7f65862aa412431e33dec83a9614f19ea66f4b24e1142a5cf4aeb5e8` | | 2002-01-16 | Supplement 3 · AP | Manufacturing (CMC)-Control | None listed | `512cb4582d9ac6cfa98375e740e64badf1a66f99deec5540f0e66544f6802eb2` | | 2002-11-12 | Supplement 4 · AP | Manufacturing (CMC)-Control | None listed | `eda0c4f85cb96da244291faf9c6dae6e1368916981ef30cc6606aaadb82351ed` | | 2002-11-15 | Supplement 5 · AP | Manufacturing (CMC)-Control | None listed | `8470dd76c3e7d177efed1071e38d2ee3ee4cc770ebee226268b5919a26d726aa` | | 2004-02-24 | Supplement 10 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20928slr010ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20928slr010_glucagon_lbl.pdf) | `444b9cf0c0a54a9027910308d0fe8d5cccbe91f88dc01f1264d2df1c3363f329` | | 2013-09-27 | Supplement 47 · AP | Manufacturing (CMC) | None listed | `7a2f6b5fa649020a2274bf37ff77b4b9b545e49c003399e1ff82c1296a1a96ce` | | 2014-03-27 | Supplement 48 · AP | Manufacturing (CMC) | None listed | `a95d1f3d8ffa0047a61f9c6c21b4d9e996204ef89f612c08c630d33aacf1f768` | | 2014-08-11 | Supplement 49 · AP | Manufacturing (CMC) | None listed | `f1977f8064d2edb2d98cd02c69f84e669e8f440e7706aa35728ab1dafe0006ff` | | 2015-07-21 | Supplement 50 · AP | Manufacturing (CMC) | None listed | `51216856653c4580e6830ad7bb3fad8a0653542c37bc8be4da4bcb1f943dac5f` | | 2015-12-18 | Supplement 51 · AP | Manufacturing (CMC) | None listed | `b1b7201396468af8c950c5565f321f6d47fd9d9e0f914f4ee76091dd4ca90ada` | | 2018-04-18 | Supplement 55 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s055lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020928Orig1s055ltr.pdf) | `16e175d122fb00cf3a15b72fb16bdfd637a1309454938dabd0b12f785458a1b9` | | 2018-07-06 | Supplement 56 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020928Orig1s056ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s056lbl.pdf) | `67f96891932601c948013cb33f853c530eee7eff99cad07bb605ac86c9976e5a` | | 2018-12-20 | Supplement 57 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020928Orig1s057Ltr.pdf) | `9b96c2441a9c51ba06a6ec317fdaaf09c742204037efc9711aed78df5e3ba96f` | | 2021-01-26 | Supplement 60 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020928Orig1s060ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020928s060lbl.pdf) | `1f745fcecd2bfac69f1bbdf9559e44b157bfdc3c4fd2a74243b539651aa51192` | ## NDA021008 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021008/ - Profiles: Octreotide - Submissions: 29; documents: 34 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 1998-11-25 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21008lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/021008.html), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21008ltr.pdf) | `28e53759dc2b679b75eb044d65b6c21f10dd514154a7a4e714ef6d30c462adc8` | | 1999-05-17 | Supplement 1 · AP | Labeling | None listed | `bdcd14da41db8390b668302a67a4e174a6b8bc0aa40b2ccff2000c3f1bedd119` | | 1999-07-13 | Supplement 2 · AP | Manufacturing (CMC) | None listed | `fa52861db55ad0d122793eb861c0f142eebbe90bb97bece92d04e91da4c7dcc5` | | 2001-07-02 | Supplement 3 · AP | Labeling | None listed | `61295d78609871d7858048caee56e51fdbe2b5ad765bc50bdf05ff88f7305911` | | 2002-01-03 | Supplement 4 · AP | Manufacturing (CMC) | None listed | `76a49d9b1bff15761830b104cde7dee866c50e6063d9ad35be8b0e1b92ac320b` | | 2002-05-13 | Supplement 5 · AP | Manufacturing (CMC) | None listed | `f1b3785728121f2356a69e3b0c669aef0f89efd1c2f184f22ae25de0d13e895a` | | 2003-12-18 | Supplement 7 · AP | Manufacturing (CMC)-Control | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21008scs007ltr.pdf) | `f304c8d9c2b92dccd0adddbcc9ac73c3091064eeeb2135b24a869c040a891dfd` | | 2004-04-19 | Supplement 6 · AP | Labeling | None listed | `e11d2d1286a425210144adfa16453297ba0b1490a97c6763b4fd77b05a0c2bed` | | 2004-04-19 | Supplement 10 · AP | Manufacturing (CMC)-Control | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21008scs010ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21008scs010_sandostatin_lbl.pdf) | `040cc02865808e93a75510db836582aed4f78169b9c09fd5280dd6bab949126a` | | 2004-10-14 | Supplement 15 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21008s015ltr.pdf) | `074ab06ef872277cf5d45c880edb34aa076870e0cae6816bdec592339020ae5e` | | 2006-05-10 | Supplement 18 · AP | Efficacy-New Patient Population | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf) | `1603704c9bbfbdc02c4e4464a4c6d6bf7579da1a61c5f366a134b786aa30d5f9` | | 2006-05-10 | Supplement 19 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021008s018s019lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021008s018,s019ltr.pdf) | `b2770659b42151eab8affd9599c1c9099735031251f5d56a334bfee54992ed5b` | | 2008-03-03 | Supplement 21 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021008s021ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021008s021lbl.pdf) | `375b4db58ad0910ea4d6ecadd698c74d401ca644db90bb7e967f4b829ae96258` | | 2010-01-25 | Supplement 23 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019667s058,021008s023ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf) | `f0c1bb3ea5f1db54275fb64e69e554da0fa3be1d10e595551316743175cee01c` | | 2011-09-30 | Supplement 25 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021008s025ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021008s025lbl.pdf) | `bd0961b45936bf5c81335c3b9ab2aeb1d84e1f052fa9d1937bb60c989ca05067` | | 2012-11-30 | Supplement 27 · AP | Manufacturing (CMC) | None listed | `7af2a239173ac45540c31a3446d29139e8d075cb525c84bb576681c052b95f1d` | | 2014-01-30 | Supplement 29 · AP | Manufacturing (CMC) | None listed | `7bbd1bd9afc239e8ffdd203b79b6b889d13085b9287d6e38f16a169730e01ec9` | | 2014-05-19 | Supplement 28 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021008Orig1s028ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s028lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021008Orig1s028.pdf) | `3d4685838ba8c74fec38a88ff32f3c63c54f39479bcfd1ccb32ed65b08b87f28` | | 2014-07-17 | Supplement 30 · AP | Manufacturing (CMC) | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021008s030lbl.pdf) | `576f0e33003c9905dcb55b5f9830feb75654f0fa8301e9d310629520da94cfa4` | | 2014-08-21 | Supplement 32 · AP | Manufacturing (CMC) | None listed | `e86f3d86cd998f51bd98675117eea7f5936dcc451b0a2d792dad3e5ba60b61ad` | | 2015-05-18 | Supplement 33 · AP | Manufacturing (CMC) | None listed | `8058495dfb46114466faf5426c809cbeea50942bc8bace80d070ab1164bd8e7b` | | 2016-05-20 | Supplement 34 · AP | Manufacturing (CMC) | None listed | `ba2adf96aba7a57eb6268efc905e6e25da0b3ecd4a89c1e24ad9d87727a483eb` | | 2016-07-22 | Supplement 35 · AP | Manufacturing (CMC) | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021008s035lbl.pdf) | `ce8268ab1c2a0ad233ea3729b68801d31748ff5d8e899cb5afdcd1dacbfaf269` | | 2018-12-21 | Supplement 36 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021008Orig1s036lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021008Orig1s036Ltr.pdf) | `c5385c43f008f0eb10c43cfce12b7b22c6633c4379282f88dd85cbd83c4098f9` | | 2019-04-11 | Supplement 43 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021008s043lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021008Orig1s043ltr.pdf) | `d0f9fb598823122089d84888993386a8affb68bb291a77400bdcc4c616962669` | | 2021-03-30 | Supplement 41 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021008Orig1s041ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021008s041lbl.pdf) | `7d735343b289411281ef975180d249ce0e5e317c9f140b05c88ab865091b0c17` | | 2023-02-09 | Supplement 46 · AP | Manufacturing (CMC)-Facility | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021008Orig1s046lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021008Orig1s046ltr.pdf) | `436b1537a951340c9dba26b7da0bc56e9f10f4ead6711f3247751c9940d6b7c8` | | 2024-01-05 | Supplement 47 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021008Orig1s047Corrected_ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf) | `806b92a694f5fa6fdde7ac14c264bd4e3fd19b035d7f9d9dcc52d7048332af4d` | | 2024-07-11 | Supplement 49 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021008Orig1s049ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008s049lbl.pdf) | `b4844ad68c65b47e39db200a3c6d6fcbaaec100bf4aa1ae4b9a269daf8d2d8ef` | ## NDA021060 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021060/ - Profiles: Ziconotide - Submissions: 6; documents: 10 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2004-12-28 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021060ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-060_Prialt.html), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021060lbl.pdf) | `68f290efbe21f9f19a4c9f7140e1e2897b36cb35d56b5756ebd78ac4c8ffca1e` | | 2005-05-26 | Supplement 1 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021060s001ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021060_S001_PRIALT.pdf) | `d23726e638d169e149ce092dd5ba9bf1eb3d7f70c5d6157cf55a541e2bcb0a08` | | 2007-04-18 | Supplement 3 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021060s003lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021060s003_LTR.pdf) | `7b3287a26ec4f16bb7df6f915bcd06168572274b42a5ef4ff385868ffda525af` | | 2011-09-01 | Supplement 6 · AP | Labeling-Patient Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021060s006lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021060s006ltr.pdf) | `f4275242edd4b789a5787a1b3959dbcac39a85981179fb84425c01cd9f0908d7` | | 2012-12-19 | Supplement 10 · AP | Manufacturing (CMC) | None listed | `2b374594295b872552bbe33d5434a563a57c924fbdb769ab6ba8970fabb75430` | | 2023-03-16 | Supplement 12 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021060s012lbl.pdf) | `3e5f46e58f25fa0f0ab959c7db02a1940905689db80e2c861a7c684ecb865d2d` | ## NDA021088 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021088/ - Profiles: Leuprolide - Submissions: 18; documents: 11 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2000-03-03 | Original submission 1 · AP | None listed | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/02-1088_Vidaur.html), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21088ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21088lbl.pdf), [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm) | `e9a42a7db8892524a81136792286adc267a6c1d2be400c455ede189b273da8ff` | | 2000-09-18 | Supplement 1 · AP | Manufacturing (CMC) | None listed | `3c71d2eb949e3c7e477a5ab8ff70f2cf8952dba6e96b0d801b334233b701500b` | | 2000-09-28 | Supplement 2 · AP | Manufacturing (CMC)-Control | None listed | `68db0f80bef486b64f3eccb7cdb0757c86141f08e159e1de4d7590d65d2ff079` | | 2000-10-16 | Supplement 3 · AP | Manufacturing (CMC) | None listed | `74030225e2bae05631d406889c5712fa5574ffea2229de2adef66588123b6f42` | | 2001-01-24 | Supplement 4 · AP | Manufacturing (CMC) | None listed | `c41842fe3cf48f4a0807fdd7462a394845a22102eb1aa67082aa2acb10c1c348` | | 2001-06-08 | Supplement 5 · AP | Manufacturing (CMC) | None listed | `75839dcc2406150b991c1510bd80f394016ab09a6a66dcd46a82463b8b4580fb` | | 2001-07-05 | Supplement 6 · AP | Manufacturing (CMC)-Control | None listed | `e351b9362b84a957f77eeb91f4d076f61b8dff76777bca14d92cd7e73e86fb16` | | 2001-08-08 | Supplement 9 · AP | Manufacturing (CMC) | None listed | `7cb6c945b14890f033d70da109b2ee7a4dc3499b8dda1e46aba5c0b2d91390c0` | | 2001-08-13 | Supplement 8 · AP | Manufacturing (CMC)-Control | None listed | `1cd3cd01119dec64ade9da22c9d157ef983b74f153f444c62abf620ad4058a9e` | | 2002-05-17 | Supplement 11 · AP | Manufacturing (CMC)-Control | None listed | `42d06925b1ab990c1c2d161b0749468f2ec58af0e6040ce19e59a9688b8f46ff` | | 2002-05-23 | Supplement 12 · AP | Manufacturing (CMC) | None listed | `77d901ab88d9fad190bda153831f7fbb04491b30a443813a0c232b1439a3eb01` | | 2002-05-23 | Supplement 14 · AP | Manufacturing (CMC)-Control | None listed | `674c5770215a07dd06d0c0175be2d1643251e8903fed5d41f6733a7fdd1ea5bd` | | 2002-08-23 | Supplement 13 · AP | Manufacturing (CMC)-Control | None listed | `5f7e0a57e127c6214c4a0dbc4a454bace71a814333ef61478c8d6a2c45ccfc16` | | 2002-10-21 | Supplement 16 · AP | Manufacturing (CMC)-Control | None listed | `6552ef49c4d6d1565cc6b6af1facd9cc8c9ec12d2e76b2b5860f710643625bdb` | | 2003-08-01 | Supplement 15 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21088slr015ltr.pdf) | `ec948757d2ad936e1f1642083fa0780af5d08e1cf0bba6842e465ce13de296ea` | | 2005-09-08 | Supplement 7 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s007lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s007ltr.pdf) | `3a29926720948aab504fd1244989f840c185446e43a9103511155df03ff64b97` | | 2005-09-15 | Supplement 22 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s022ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s022lbl.pdf) | `437babb97c02c29b0dbe8546b8cab0dacb69d898b8c9e563cd35fa49a591d1f1` | | 2011-01-14 | Supplement 25 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021088s025lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021088s025ltr.pdf) | `3b5e0e8588db882e8682dafdd5faa417ebbdfd5ae0a3f1ea699b5f47366cd7bd` | ## NDA021318 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021318/ - Profiles: Teriparatide - Submissions: 26; documents: 36 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2002-11-26 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-318_Forteo.html), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21318.pdf) | `17ee559fb45a7848327d48b6a263054973e4a1b23a875b5168cb6d8b3cf05709` | | 2004-06-02 | Supplement 2 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318slr002ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318slr002_forteo_lbl.pdf) | `2800ba3d543cef7e2658cf2a907a2adf2f398abf8fb485687d4fe176b60b6cb4` | | 2004-09-03 | Supplement 4 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318s004lbl.pdf) | `2f13adfc49e284432c8203530704125a26e7dd01563529243767a7dd372ed828` | | 2007-05-19 | Supplement 9 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021318s009lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021318s009ltr.pdf) | `8dbb262d59f895832fdcde4b3db86746c0a13136e876aa223b0f51f8fefe4bf6` | | 2008-02-28 | Supplement 15 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s015ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021318s015lbl.pdf) | `1118e280bb7e1d78eb497122ce0684c4d7ce1eb25502d0e0566a2d09cf9d8cc5` | | 2008-06-25 | Supplement 16 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s016ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021318Orig1s016.pdf) | `96a67dce32b07497f2106a064d08b8561b8466f3a83f1ac2e655d44300df8b24` | | 2009-07-22 | Supplement 12 · AP | Efficacy-New Indication, REMS-Proposal | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021318s012ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf) | `b212d29ede666ad06df0cf903057c596ed5891c0ae9034869445bef18565305f` | | 2011-08-10 | Supplement 26 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021318s026ltr.pdf) | `49ec33e709f6704e1e155424ee0e13be2229bedaae1ce405f0f8ebb8d1262fe7` | | 2012-03-13 | Supplement 27 · AP | Labeling-Medication Guide | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021318s027ltr.pdf) | `93f48862d53022cd5708d11f41ccdbb225e1aab5d1daaed4f0852a094ee0c9b6` | | 2013-02-15 | Supplement 32 · AP | Manufacturing (CMC) | None listed | `8f2682df780b4a295adc7a840493be0c4136fcd56a940e4d0d05c2acff72c66e` | | 2013-03-13 | Supplement 33 · AP | Manufacturing (CMC) | None listed | `9a51760982e8bf3a6f06591ceb7f6760552dda5e7523ae33a8f064a7e52144c8` | | 2013-08-02 | Supplement 35 · AP | Manufacturing (CMC) | None listed | `ed9a2022b4af8d5611bae627270cd9668a7799dbddc940056fb56e670b0c3a40` | | 2013-08-30 | Supplement 36 · AP | REMS-Modified | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021318Orig1s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021318s036lbl.pdf) | `5aca1c689fc2b6eeedfd05a1b1ea5bd4957eadc59b09935498dd4bf23708fd58` | | 2014-01-24 | Supplement 38 · AP | Manufacturing (CMC) | None listed | `40d0518092041dfab00c9000e3f51d9d75d293d9e1fa5930f056b510446bb0f1` | | 2014-03-05 | Supplement 37 · AP | Manufacturing (CMC) | None listed | `d2fc3485f3da28e083e0b9c98c67b196d28f2fa0104fe39932424862c49208d6` | | 2014-04-11 | Supplement 39 · AP | Manufacturing (CMC) | None listed | `b6664dc008e12c49078d07a3dc2a0ec7db5e6f490f93cb4104fef040a58e02d4` | | 2014-08-13 | Supplement 40 · AP | Manufacturing (CMC) | None listed | `d726783a7c3be873ac7e356dee077fc019aea07c6cd66b7909e11b366b242464` | | 2014-09-12 | Supplement 41 · AP | Manufacturing (CMC) | None listed | `49cb6975ff69011e757b5fbf90ced3ec929f35f30edb13db71b009711e6a6bef` | | 2015-11-23 | Supplement 44 · AP | Manufacturing (CMC) | None listed | `3461cb21f4540b80602496b558c96deecbcd6039e0bfbb3b4e5e4a2aebb33db1` | | 2017-04-28 | Supplement 51 · AP | REMS - MODIFIED - D-N-A | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021318Orig1s051ltr.pdf) | `c8d4990dc4b5f3f9f9bba5e94d6c5a7162faac7f445474f46610b0e6e97b4151` | | 2019-10-03 | Supplement 52 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021318s052lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021318Orig1s052ltr.pdf) | `8a35e2a662be44076bd93951b9837f103134de2950675457ba43df684b935598` | | 2020-04-06 | Supplement 53 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021318Orig1s053ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318s053lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/021318Orig1s053.pdf) | `9c97d9f072bb10565b63d5909f828bf1cee83b687278a8f7359d383123dbed80` | | 2020-11-16 | Supplement 54 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021318Orig1s054ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318Orig1s054lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318Orig1s054lbl.pdf#page=16), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021318Orig1s054.pdf) | `959f697978af0c5e285dd86576cf93045bd4d99f9fa3322cb99fd44af3bae995` | | 2021-09-07 | Supplement 56 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021318Orig1s056ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021318Orig1s056lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/021318Orig1s056.pdf) | `65b568a475620cab8b6b4cd5e032c5c1a751d4b187e5da4e13bac3d9ec04ee70` | | 2024-07-24 | Supplement 57 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021318s057lbl.pdf) | `42a59345a8c3ae7127aa058ebc30d9fe0dc65ecb22872bf3f7e835349e9b9650` | | 2026-08-03 | Supplement 59 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021318Orig1s059ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021318Orig1s059lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021318s059lbl.pdf#page=17) | `ea1dee1931d3ebcd073d601005b2b35a02dbb1aa6a67d1f1158dc0818cf90b19` | ## NDA021332 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021332/ - Profiles: Pramlintide - Submissions: 11; documents: 20 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2005-03-16 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021332ltr.pdf), [Medication Guide](https://www.fda.gov/downloads/Drugs/DrugSafety/ucm089141.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021332lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin.html) | `e8ec3a293e5c4a1ad3f7e1989036144763f6a71968843da1d628bcf4fe723d36` | | 2007-09-25 | Supplement 6 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021332s006ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf) | `5a18fbbe2700f59f3c31059fde03c1f7e38888c181950b932433542540a783ba` | | 2008-08-04 | Supplement 10 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021332s010ltr.pdf) | `be3ee2dceb945cbfb645a3e41d238bdfc99e33e59f30297e100d1432bc51e3be` | | 2012-01-03 | Supplement 20 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021332s020ltr.pdf) | `362c78abbd545d9390f77ee98d0c6bfb8518abbd092745810b5f6d4fcfffd5a9` | | 2014-06-27 | Supplement 7 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf) | `74e383ea37bdcd04dcc5def0f7a92b884f8d8cbe1c1a11d65fb7623487df0f5d` | | 2014-06-27 | Supplement 16 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf) | `1398f97177f49e9a876734887b517892759a53f62bef4046e4c09a4725cbed17` | | 2015-02-25 | Supplement 23 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s023ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s023lbl.pdf) | `a2f3d7f43677fd47275894dc678dbed2931366634b304d1a9e789fb19871d6c7` | | 2015-03-20 | Supplement 25 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s025ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s025lbl.pdf) | `b263d78baf14b940c4ceb36d29098d6985cfb69b051b7f115dc89e83f8bce841` | | 2015-08-07 | Supplement 24 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s024ltr.pdf) | `88d45db28db94e77c65caec8a3c8eb5cfe8f716077686e3149fd5d2a340af4f8` | | 2017-03-08 | Supplement 26 · AP | REMS - MODIFIED - D-N-A | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021332Orig1s026ltr.pdf) | `7606be75f2dee1807679fa57feca8d12262368876a62b39808aa16f735fbb309` | | 2019-12-18 | Supplement 28 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021332s028lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021332Orig1s028ltr.pdf) | `de816c25065e394e48fa4c0f2484d4aa22959dd6c839c6ca76b2814cf28a783d` | ## NDA021343 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021343/ - Profiles: Leuprolide - Submissions: 25; documents: 38 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2002-01-23 | Original submission 1 · AP | None listed | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-343_Eligard.html), [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21343ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21343lbl.pdf) | `d62ff469415f3c543bb7f59bf07db1e3d5dc5ab037cb0a3243b1d29568906e06` | | 2002-04-01 | Supplement 1 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21343s001ltr.pdf) | `60b412fc551fbd7d53260a2dc1f93e816d6d7a3c3d4fba2efaf82cb8338776a3` | | 2003-07-03 | Supplement 2 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21343slr002ltr.pdf) | `50a074fd6d771711c1c8e636378f0a500fca6dcaa8c4df001e259ba8d5aa58bf` | | 2004-01-12 | Supplement 4 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf) | `db753ee4e680694f5e1a67b9408ef63c46e62499d1533d61a7ba2df639ba63e8` | | 2007-11-08 | Supplement 15 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015,%20021488s010,%20021379s010,%20021731s005ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf) | `d4eb8e470d92aa509933430e2ea535d61ae45e56c24c830f9bb1cf40a19ec94e` | | 2010-10-05 | Supplement 18 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf) | `4962a8e91fe64c55b43a8dcb784f443bc87b18f403fcf4e7330bb3815b8b2946` | | 2011-01-14 | Supplement 19 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf) | `b93ff31159f883d82eaee52b1bc38182ae6d4f9a9ae1d372f0645dcb9b93279c` | | 2011-04-08 | Supplement 20 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf) | `1ae99010621daf3021becee9331ee4499111e70353e17ad10cd9836921625a7c` | | 2013-02-27 | Supplement 27 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf) | `a3d2f559a065b46209404ec9dad9ee14dc5baf38d848a957a5dc1506c391b029` | | 2013-04-09 | Supplement 26 · AP | Manufacturing (CMC) | None listed | `69e2bbb2ee05a1fa31fa22147acdc3bd6d5c819e39b7a639eae8349c100c2f12` | | 2014-05-30 | Supplement 29 · AP | Manufacturing (CMC) | None listed | `7a09417caa2dfe5b82f1e8b267d3379ef2f511414fa58d25738e49cf37f4cb9d` | | 2014-07-18 | Supplement 28 · AP | Manufacturing (CMC) | None listed | `d531637ee79abe503f0d1d45ad938aaae9cf748288561c5485e1d3baf8153a9e` | | 2014-10-10 | Supplement 30 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf) | `541a959a9f7fded0f75d432f4f58b4c611b0ed52d37e69396f3e267e29ab8841` | | 2014-10-10 | Supplement 31 · AP | Manufacturing (CMC) | None listed | `92862e1a4f8a64f72945b89aa78a955e3c8bc0a31d8f9a2f422efa8acf4d8d09` | | 2015-10-26 | Supplement 32 · AP | Manufacturing (CMC) | None listed | `9bbfa266521a71b052f23cd68ab1812ced21450c4598092c46a17b0b113a0fb4` | | 2016-02-29 | Supplement 33 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021343Orig1s033.pdf) | `fd759879dc3f1178ce1b96cfe237534c90a2ecfb6fa9bc86d2d364045051dfb2` | | 2017-01-13 | Supplement 34 · AP | Manufacturing (CMC) | None listed | `b0a38dba49ad99eec2509b85f64be3174a61be256a59ae9efa5288343ed3d9fe` | | 2019-02-15 | Supplement 39 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021343Orig1s039,021731Orig1s037,021488Orig1s036,021379Orig1s041ltr.pdf) | `47cdb68efeeeb432966d9dbb3f0aa199733187df99f4e097e66c2540266f446d` | | 2023-07-20 | Supplement 47 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf) | `50f7023684524c3f60dec2eaf0663e2c1ced7b19ecef152753edbf6218c504c1` | | 2023-07-20 | Supplement 48 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf) | `017762c6e5a0d1f22d53c044ce99b179ed103fcc465a16e412a976d1a914189b` | | 2024-01-23 | Supplement 51 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s051,%20021379Orig1s053,%20021488Orig1s048,%20021731Orig1s051ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343s051,021379s053,021488s048,021731s051lbl.pdf) | `9cf5ee09a181f4c426c2118eb20ba1ef60419165a3b607ad550237c15482d573` | | 2024-05-21 | Supplement 52 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s052;021379Orig1s055;%20021488Orig1s050;%20021731Orig1s052ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343Orig1s052;021379Orig1s055;%20021488Orig1s050;%20021731Orig1s052lbl.pdf) | `0bef576f50a83ea921fd0fd6d46a034932caf893fddf38b3f2110069880ca2ea` | | 2025-02-04 | Supplement 55 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021343Orig1s055,%20021379Orig1s058,%20021488Orig1s052,%20021731Orig1s055ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021343Orig1s055,%20021379Orig1s058,%20021488Orig1s052,%20021731Orig1s055lbl.pdf) | `2c0de5b304452463435435b93e99dcbfa537549e1954a8ab7e4976ae985e2a97` | | 2025-02-24 | Supplement 56 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021343s056,021379s059,021488s053,021731s056lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021343Orig1s056,021379Orig1s059,021488Orig1s053,021731Orig1s056ltr.pdf) | `492733af3e74217eaf1e176ecb1186078fd5e0b8fe6fb4714c775f9fe793b9b0` | | 2026-05-06 | Supplement 60 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021343Orig1s060,%20021379Orig1s065,%20021488Orig1s057,%20021731Orig1s062ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021343s060lbl021379s065lbl021488s057lbl021731s062lbl.pdf) | `75eb697070d1847e8768dddd8851d644accfe26025bf2f51c103056d201c014d` | ## NDA021379 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021379/ - Profiles: Leuprolide - Submissions: 22; documents: 36 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2002-07-24 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21379ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21379lbl.pdf), [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-379_Eligard.html) | `c58f8ceed501eeb719e1c2151456e4d22ef645691b925935449542570bdf89da` | | 2004-01-12 | Supplement 2 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021379_s002_ELIGARD.pdf) | `d6a53175ee30572ab61f63bcfd62c9704cb28b0b40ba72495b055a9e8d7ab650` | | 2007-11-08 | Supplement 10 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015,%20021488s010,%20021379s010,%20021731s005ltr.pdf) | `c851b0219e6c960c6c88ae2946b3875338a412f63bf33b69527afd0341c3a617` | | 2010-10-05 | Supplement 14 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf) | `73a9192439368a03b8bdc083e3402c8cd6aed82e2c1a8e30efc9725f010a7359` | | 2011-01-14 | Supplement 15 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf) | `e84765ffeb581360c2833a77d3183018c24f8d3518801c5781462bdbdd5e3fa6` | | 2011-04-08 | Supplement 16 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf) | `1f3b77d383bee2713b4c97f05fd388d28664bb33f651ee6d258a0b367f83520e` | | 2013-01-25 | Supplement 22 · AP | Manufacturing (CMC) | None listed | `2723577cd22a4bfcd9bdf0d6570861c7662eb7b51fd92989c5bc7bd4bbc0b7fd` | | 2013-02-08 | Supplement 23 · AP | Manufacturing (CMC) | None listed | `d8323fd6747e2863504d9423016708c9ebe006fd3f53f0cac82796ebde8feb17` | | 2013-02-27 | Supplement 25 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf) | `fa02c87ea34320d944feb764ca4a9a496e6a9ad1607d610c99637df121e3c984` | | 2014-02-03 | Supplement 27 · AP | Manufacturing (CMC) | None listed | `c0b6b2a234b90261e1c633634680b75441ef86921891f9f4fa845d5170c5d574` | | 2014-04-15 | Supplement 28 · AP | Manufacturing (CMC) | None listed | `7f7adc01e755cba3a54a3303cde9b350d104e6abe1c172424dd09cc8c4179e61` | | 2014-07-18 | Supplement 26 · AP | Manufacturing (CMC) | None listed | `ce493c33b8d6aaa70daac93cba8502442cdcca276f027c01c743302b9cda14d2` | | 2014-10-10 | Supplement 30 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf) | `02a54328472f62736824b168f8de09a06f6e1b70d20183490c728a5774846f81` | | 2016-02-29 | Supplement 33 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf) | `a0bfcf44c38a63fa24fb87a0ffc856b082017dfe9e50168e45e93fddf242ce14` | | 2019-02-15 | Supplement 41 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021343Orig1s039,021731Orig1s037,021488Orig1s036,021379Orig1s041ltr.pdf) | `a2f5f06072a456d1b1f054d5e576dea6b95e5987f2cdf3e872a4cf35953fd2e0` | | 2023-07-20 | Supplement 49 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf) | `6b9f3653ef86e29c03d248926ed35138769d5d2ad3e879b03e848e5eaff5efed` | | 2023-07-20 | Supplement 50 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf) | `b85bf2758f7faa331d7a194f1fe36138d10838eb3d6f5bf5819bfd4ed1620942` | | 2024-01-23 | Supplement 53 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s051,%20021379Orig1s053,%20021488Orig1s048,%20021731Orig1s051ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343s051,021379s053,021488s048,021731s051lbl.pdf) | `188a2eb2de2fdcc90c73ffe9b737f8a928ce1dc03b65a45999b5e00a2d083af9` | | 2024-05-21 | Supplement 55 · AP | Labeling-Container/Carton Labels | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343Orig1s052;021379Orig1s055;%20021488Orig1s050;%20021731Orig1s052lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s052;021379Orig1s055;%20021488Orig1s050;%20021731Orig1s052ltr.pdf) | `7edbe866338259ba62fc8763d801ac7851b6903beb9290cba5e34924579ae79b` | | 2025-02-04 | Supplement 58 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021343Orig1s055,%20021379Orig1s058,%20021488Orig1s052,%20021731Orig1s055ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021343Orig1s055,%20021379Orig1s058,%20021488Orig1s052,%20021731Orig1s055lbl.pdf) | `49b9b3123c5a0ae6bebfa39aec3d9509adb0a56ad7c5eaa8ec409ad6fd146286` | | 2025-02-24 | Supplement 59 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021343s056,021379s059,021488s053,021731s056lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021343Orig1s056,021379Orig1s059,021488Orig1s053,021731Orig1s056ltr.pdf) | `51d7b8662a9d75c378b6761ad13ff38f79d6cd207bfc2c7389c294d8cf1c3e90` | | 2026-05-06 | Supplement 65 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021343Orig1s060,%20021379Orig1s065,%20021488Orig1s057,%20021731Orig1s062ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021343s060lbl021379s065lbl021488s057lbl021731s062lbl.pdf) | `41f21aaeb16a6cce573f2e183f5b4cc768a99795f753dfb56cf9fc253bcdaa2a` | ## NDA021488 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021488/ - Profiles: Leuprolide - Submissions: 17; documents: 35 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2003-02-13 | Original submission 1 · AP | None listed | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021488_eligard.html), [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-488_Eligard_Approv.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021488lbl.pdf) | `4ce0dbc8be66f3f52c0adf607daa946fa6052e844fddd2e394e37d3696f45d49` | | 2004-01-12 | Supplement 2 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf) | `3c6fbebd7c9952479370fed99b902a97bf3844e4b50703d1bc9fcd9e53955989` | | 2007-11-08 | Supplement 10 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015,%20021488s010,%20021379s010,%20021731s005ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf) | `5f192e037c9ac79277941ae205b85f4eadfcf378137efca30b6c446d70843c14` | | 2010-10-05 | Supplement 15 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf) | `80b34c6d79c4baabe0a1301494c4c7dd46b564e4fec702381bf4ea80a39f4b2c` | | 2011-01-14 | Supplement 16 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf) | `3e0dbe047b8315810b4c66976cce9b980bcf472a8d2cde5299070d6b20d3a5c2` | | 2011-04-08 | Supplement 17 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf) | `978ee85fb456204f979ce32e2ba801868bcaa94a20cdb22971b573cf241e568d` | | 2013-02-27 | Supplement 25 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf) | `c762b51e7f2e5244643f3ee62cb9666bc93850892990cd5230ed46a012400818` | | 2014-10-10 | Supplement 27 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf) | `40b2afe9e5ddaf1b783ee9360062cabf7025b056220abfe4d719ba2ea07ef0ba` | | 2016-02-29 | Supplement 30 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf) | `baff50f555f653943cde9f54b1911e4a0450de449c075bab43f9f158708f3c41` | | 2019-02-15 | Supplement 36 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021343Orig1s039,021731Orig1s037,021488Orig1s036,021379Orig1s041ltr.pdf) | `5a301077a3be6d45b7acea124e574c0fc7e4a9c3221c34c42e3ade333d47a0c4` | | 2023-07-20 | Supplement 44 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf) | `77b47f1145ef5cd747e0556efddd0849dda66673bd0eb1d819acd2b1d74b096e` | | 2023-07-20 | Supplement 45 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf) | `80298ffb4b39f16fea55e233c460da0083208574c1dce536b77eebbe82e9793f` | | 2024-01-23 | Supplement 48 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s051,%20021379Orig1s053,%20021488Orig1s048,%20021731Orig1s051ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343s051,021379s053,021488s048,021731s051lbl.pdf) | `ccf7152d3244b4df4e3b344e31118fc1f133302e49fe66a5ccbdf02464023836` | | 2024-05-21 | Supplement 50 · AP | Labeling-Container/Carton Labels | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343Orig1s052;021379Orig1s055;%20021488Orig1s050;%20021731Orig1s052lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s052;021379Orig1s055;%20021488Orig1s050;%20021731Orig1s052ltr.pdf) | `f4339af407f55e6fde9be2873b740487a9b51b0662de99d21db1c8646aec450d` | | 2025-02-04 | Supplement 52 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021343Orig1s055,%20021379Orig1s058,%20021488Orig1s052,%20021731Orig1s055ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021343Orig1s055,%20021379Orig1s058,%20021488Orig1s052,%20021731Orig1s055lbl.pdf) | `74a2fd21f36547f473d16c2cdc8032062a16d640bad27f94cea70ac6496623a3` | | 2025-02-24 | Supplement 53 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021343s056,021379s059,021488s053,021731s056lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021343Orig1s056,021379Orig1s059,021488Orig1s053,021731Orig1s056ltr.pdf) | `8a56195439df5ec13b54a896fbcd4c7f12b2074c73e70c76565ce2cfd07ddb57` | | 2026-05-06 | Supplement 57 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021343Orig1s060,%20021379Orig1s065,%20021488Orig1s057,%20021731Orig1s062ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021343s060lbl021379s065lbl021488s057lbl021731s062lbl.pdf) | `ad224005d6f96f4c6d6a44d918286d03a5e4e58d27c38fbbb6f521ff45b90c22` | ## NDA021731 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021731/ - Profiles: Leuprolide - Submissions: 20; documents: 33 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2004-12-14 | Original submission 1 · AP | None listed | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021731s000_EligardTOC.html), [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm) | `cb0ad1a214e75b4e71633ab95fb0e682f029648c4088752486c6bf2faf4b7576` | | 2006-09-29 | Supplement 4 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021731s004LTR.pdf) | `c56c2adf8d8317907e4a8dad2ac6e370a18e5a39f4d21602f67087cc3d648367` | | 2007-11-08 | Supplement 5 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015,%20021488s010,%20021379s010,%20021731s005ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf) | `50e2e68d92fb45501326c39453a4866c62a5330b59d20a96efb434cd6f1a86e8` | | 2010-10-05 | Supplement 10 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf) | `0ea8a2efe5b8466d7bad94a6c9203c87500bc6807eba9049aacc05e9021b2c64` | | 2011-01-14 | Supplement 12 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf) | `f8db075979477c9096b18c21bac83d8e57dea4eebb358f1671d22d1f4b668c40` | | 2011-04-08 | Supplement 13 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf) | `f3c4a21d3cfa2d3ba4f5216c690ab1456ed82bb33fbd10084e79b5e49dfa7346` | | 2013-02-27 | Supplement 23 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf) | `0c993b4edca935cf360df71785cd199226ac1348259ceec26791cd74fd3af74e` | | 2013-04-03 | Supplement 22 · AP | Manufacturing (CMC) | None listed | `9221addc66fed5f981bc96cd8968c6b27d8f2adcfb7457fb1780f4ea6b45cd5e` | | 2014-07-18 | Supplement 24 · AP | Manufacturing (CMC) | None listed | `be697c64e6a5a0f654e94f41b75bcf5af3f998ee6c9d769b3fb245078e8e37cd` | | 2014-10-10 | Supplement 27 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf) | `0866b0874fdd138ffcc0f9d660b336a9af4f4e9183040240238b3a81ce2732af` | | 2016-02-29 | Supplement 29 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf) | `73a9bac9837cfc9b97036e9f1e02396f635380a67c130f00ba454c51f2d1c490` | | 2019-02-15 | Supplement 37 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021343Orig1s039,021731Orig1s037,021488Orig1s036,021379Orig1s041ltr.pdf) | `e262854cc979504c29af0d1bea1a1f3efb21ef7e7a8b2cb1f9e600c2359062b1` | | 2022-11-25 | Supplement 43 · AP | None listed | None listed | `48a3aa63a8efae5dbca5649e131ba06646b5da6db93e7c630d46e0b29c3f2c2b` | | 2023-07-20 | Supplement 44 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf) | `974ae2cf5c3af0a7ed84e532699ad63b72c372c9a9cf16a8c7a35d9e4c34a6ba` | | 2023-07-20 | Supplement 47 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf) | `4ca451d8255be8ec1bc0629a902e3f8b6c5e718b3ceba0ab23146ed9d7e6df89` | | 2024-01-23 | Supplement 51 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s051,%20021379Orig1s053,%20021488Orig1s048,%20021731Orig1s051ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343s051,021379s053,021488s048,021731s051lbl.pdf) | `00572e5c85afcfdece2e81fccb67dde3c2e47d799d9e8abff00dc5168d42aa64` | | 2024-05-21 | Supplement 52 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s052;021379Orig1s055;%20021488Orig1s050;%20021731Orig1s052ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343Orig1s052;021379Orig1s055;%20021488Orig1s050;%20021731Orig1s052lbl.pdf) | `f2f0e6743f2ac8070cc4021cd59f27cb729454fee8b21e802180c4e9a92b811f` | | 2025-02-04 | Supplement 55 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021343Orig1s055,%20021379Orig1s058,%20021488Orig1s052,%20021731Orig1s055ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021343Orig1s055,%20021379Orig1s058,%20021488Orig1s052,%20021731Orig1s055lbl.pdf) | `df20fc436aac6aa038438a948560ee038ca4549643fa87d223e442bbdd73662f` | | 2025-02-24 | Supplement 56 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021343s056,021379s059,021488s053,021731s056lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021343Orig1s056,021379Orig1s059,021488Orig1s053,021731Orig1s056ltr.pdf) | `8384d70ae493c96e98a4391c3c95c228343dbba16c16e97c0115fe4e70960b79` | | 2026-05-06 | Supplement 62 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021343Orig1s060,%20021379Orig1s065,%20021488Orig1s057,%20021731Orig1s062ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021343s060lbl021379s065lbl021488s057lbl021731s062lbl.pdf) | `30b950054734bd70f2cb72cd174b2ecf2bb21cd669c8c9167141cd22be0d2d27` | ## NDA021773 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021773/ - Profiles: Exenatide - Submissions: 36; documents: 62 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2005-04-28 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021773ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021773lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_ByettaTOC.html), [Other Important Information from FDA](https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113705.htm) | `61c92d6e54e33b476adf95c18529c9bddc48abbd169ceaf72036cddcc3d3b9ea` | | 2006-10-12 | Supplement 4 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s004lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s004LTR.pdf) | `c602b366ebec926ac76f8c1d6ea26f7a6cd338c40ab4a683778c7e198a0d82bf` | | 2006-11-01 | Supplement 5 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s005lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s005ltr.pdf) | `0134ef6ee82b50a4dedd05af991a3529ba7ac36d494945402ba972a729d0ab93` | | 2006-12-22 | Supplement 2 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002,%20s006ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf) | `f90f8d7bf70a1d926751d57690d5185273532ebeeb9d5ecbb52b8edcbced9ba2` | | 2006-12-22 | Supplement 6 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002,%20s006ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf) | `3ecd9eb1e1f56dc78cd49fbf5c212972ef530c3c5f5c61af8dbab63dc39ed2e0` | | 2007-02-10 | Supplement 7 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021773s007ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021773s007lbl.pdf) | `0b7ac637d0379db6f27dc7c3c011f780beeab4f4b81d9197290e508977ee243e` | | 2008-01-11 | Supplement 12 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s012ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s012lbl.pdf) | `75a8463eea9984d68c9f8e6565648e2467593dac4dab01943bf97b005ba4a3ae` | | 2008-06-17 | Supplement 10 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s010lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s010ltr.pdf) | `066ba2c22352066da6995f4decef97ff9ad55d3675f6b0a4f836e1d39703fe92` | | 2009-10-30 | Supplement 9 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf) | `97983165542f772a68789d0c48a52d01c36ca114b3d88c7f3594d01af53afea6` | | 2009-10-30 | Supplement 11 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf) | `0008266de849a06f7cfac39b55aa7a06d12b7104647b7d9d749599c99444629c` | | 2009-10-30 | Supplement 17 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf) | `9883939b7fcca511db41f52e3633f2bde93b12c4876baa306a424aef513c1dae` | | 2009-10-30 | Supplement 18 · AP | Labeling | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf) | `e90efac746ac1e88d1ded859d85933fb04b0faac376498381e1c756b2f57291c` | | 2009-10-30 | Supplement 22 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf) | `19e952e22e42553a254a8b7c4de87ca5320b2a916861229a67faab126692840e` | | 2009-10-30 | Supplement 25 · AP | REMS-Proposal | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf) | `5db6de203f7924e0028f2bd7aa5e0667a42b698dd9617cf1d7ba16af46ae1ef4` | | 2010-08-13 | Supplement 26 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s026ltr.pdf) | `d10ff0a57902d5e76c7d15a34b392e1b155873916e7a663683968ef9f17c4b65` | | 2010-11-12 | Supplement 28 · AP | Labeling | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s028ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021773s028lbl.pdf) | `3654aa739714451fbc1c7d25554abb991088daa8505b4ebf7a887c36d2e51270` | | 2011-08-05 | Supplement 31 · AP | REMS-Assessment | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s031ltr.pdf) | `8cc050c4d7955f89e470a6bda3e8ff4f91418b26442f7725f70ddf5df9efed15` | | 2011-10-19 | Supplement 29 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf) | `1cf5ff9d3ba04c109a23dfdde38ad92ed75651a47bc2084f841ef02056ce3c67` | | 2011-10-19 | Supplement 30 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf) | `dcfe05144823d0bd5c3126da5470f96ba33366ae8afe85880c8751e8fc84f4fb` | | 2014-01-30 | Supplement 34 · AP | Manufacturing (CMC) | None listed | `c0fd4cf3795b1955a5e6a01c88655df52c511e48107a48915547c5ba2f9e6a62` | | 2014-04-23 | Supplement 35 · AP | Manufacturing (CMC) | None listed | `b9a2a25a2b491abd293d2647401135e0f9df99dff7d1945f61262df859563794` | | 2014-06-04 | Supplement 37 · AP | Manufacturing (CMC) | None listed | `63fc67f8f0ac703b36d406f823cdb3831f47da406ee0c5b6de2af788838e44ad` | | 2014-06-04 | Supplement 38 · AP | Manufacturing (CMC) | None listed | `6010bcfa964793accc7dafca3e70bf612f8f680c418faac205bf5ccf3ed9c82b` | | 2014-08-12 | Supplement 39 · AP | Manufacturing (CMC) | None listed | `187ded64e7dc909e3b46394c68edf707056806a135c2a086f32f249b1d33f67a` | | 2014-11-24 | Supplement 36 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021773Orig1s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021773s036lbl.pdf) | `bf1d3ba0239e6e178546f65bfa16a0160cb112ecfa6c8ac15ffecc7264f2260c` | | 2015-02-25 | Supplement 40 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021773Orig1s040ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf) | `a5dd6017171ad907afbdf11e2076386f5ffab10c78525ce9b3263ebf9e6237c4` | | 2018-12-20 | Supplement 41 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021773s041lbl.pdf) | `80068bc100ae66d2c5427ab51714cd489472006625d0167f4c5c89fe5ae7ff34` | | 2020-02-28 | Supplement 43 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021773s043lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021773Orig1s043ltr.pdf) | `97ec5a9ac1cfb18edc166a6b29ee4442bd9bc1cd857943f2eafdcd1132a8d3bc` | | 2021-06-17 | Supplement 44 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021773Orig1s044ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s044lbl.pdf) | `91237e95363a284a52d1daf2226eb6b1e75f3e3feeef6e6ce3495e87d55f9ffc` | | 2021-11-04 | Supplement 45 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s045lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021773Orig1s045ltr.pdf) | `c609529448f566bfa2f1f72395f9e932e2c293a7cec00701068552f54bde72bf` | | 2022-06-10 | Supplement 46 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021773Orig1s046,%20s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf) | `d7329035950c54166cc52fe4753c8fa38dc634d242636c2940f2f141496bcfb7` | | 2022-06-10 | Supplement 47 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021773Orig1s046,%20s047ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf) | `8386ea9d0da73f839ffb25194cd5f79ff544e70026610580e39595fd0a79fb6a` | | 2022-12-21 | Supplement 48 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021773Orig1s048ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773s048lbl.pdf) | `9c266c91b1dedda8f8ce50ef3547ab101b96acc5a75ff2cf1aa538fe5ef8383f` | | 2024-11-01 | Supplement 49 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021773s049lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021773Orig1s049ltr.pdf) | `fdb11d8a879636e772d9e1e19e25e3bfe8ec343a0a1b48d2078b6bbb77576e4c` | | 2025-05-28 | Supplement 50 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021773Orig1s050ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021773s050lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021773s050lbl.pdf#page=33) | `bade16da68edffe249ed1af410918ec1082b33aa677b3ecdddae6dcbc67c61d9` | | 2025-09-02 | Supplement 51 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021773Orig1s051correctedlbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021773Orig1s051correctedltr.pdf) | `580aaf38b80a85e649ac5b05606d85573c3fdcc5acbf8feb620e077922f1f56a` | ## NDA021919 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda021919/ - Profiles: Exenatide - Submissions: 1; documents: 4 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2009-10-30 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021919_byetta_toc.html), [Medication Guide](https://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf) | `f244afc71cdcb1e5d43d505b5c37019dc7ffb6cc440f436a6b86a601c8fc1b24` | ## NDA022074 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda022074/ - Profiles: Lanreotide - Submissions: 20; documents: 31 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2007-08-30 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022074lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022074s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022074s000TOC.html) | `01439c50fe654db35ae732f3313dae35a8394239cda166fa1cf2fe72fdea5562` | | 2011-03-04 | Supplement 3 · AP | Efficacy-New Dosing Regimen | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022074s003lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022074s003ltr.pdf) | `885a9fa349ef5a35e4b84ece902401681957d99ba2319f34c920d4deae1ba244` | | 2013-11-27 | Supplement 6 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022074s006lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022074Orig1s006ltr.pdf) | `33d718aefae16da639aaa32141fd0782db0ad9c08691ee7514e4f5f431467ace` | | 2014-02-21 | Supplement 7 · AP | Manufacturing (CMC) | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022074Orig1s007.pdf) | `94fd42182e6a823673c8c3f40ed5917b7047e08e9f038ac3010d9c256fe5bc33` | | 2014-10-23 | Supplement 9 · AP | Manufacturing (CMC) | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/22074Orig1s009.pdf) | `bfa89af27f06abb964edc9ed509732be866f14ed4b4e84e935643baf766a24dd` | | 2014-10-28 | Supplement 4 · AP | Manufacturing (CMC) | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s004lbledt.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022074Orig1s004.pdf) | `b48cf25cc025a804c5dcf24123a85772e81de02af62ca83ea33607d55bdead3c` | | 2014-12-16 | Supplement 11 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022074Orig1s011ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022074Orig1s011.pdf) | `30fedf86bfc756900146fddc1c2da7391bcaab942fe13249c8057f52d6aef16b` | | 2014-12-22 | Supplement 10 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022074Orig1s010ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s010lbl.pdf) | `1329147f57bbacc5f40c7524a1fea74ed870d7850af68765136b169806940a1b` | | 2015-06-01 | Supplement 12 · AP | Manufacturing (CMC) | None listed | `81204a2ec84c2f6dcb992b48f31d491d804919c5306c67639e1025307efc18a2` | | 2015-06-01 | Supplement 13 · AP | Manufacturing (CMC) | None listed | `f22b62189f316906ca35282543364bf2588372f54d731521b0c8e0ede175deec` | | 2015-11-02 | Supplement 14 · AP | Manufacturing (CMC) | None listed | `e066a8040c639b5f3732b4e6d46dc007502bbeba9dc27f90019ae97d8330eef3` | | 2015-12-11 | Supplement 15 · AP | Manufacturing (CMC) | None listed | `ff4ef326ff738f7ce66eada90a7a14500d6bfa4d07f3191c4d5ea59f81970c0c` | | 2017-09-15 | Supplement 17 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022074s017lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022074Orig1s017ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022074Orig1s017.pdf) | `771578c68ee39dda1d884ecbf46988cd4db1a14e5a5b2b8e6500d1494cd53189` | | 2017-10-23 | Supplement 20 · AP | Manufacturing (CMC)-Control | None listed | `f9561dc0ff83f8ac389e08c598f854468b862b31f943876d76c8c440b55be0ea` | | 2018-02-22 | Supplement 18 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s018lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022074Orig1s018ltr.pdf) | `d76b7f5e425020b03fbf78be900d9301bce8fa9afe57ee18da60eab8079537ea` | | 2018-12-12 | Supplement 22 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022074Orig1s022ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022074s022lbl.pdf) | `41b8a8e220c2aae5a32e6767591daa56d94edb0cbc73d7f197f7e2cdbf36eaa2` | | 2019-04-11 | Supplement 24 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022074s024lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022074Orig1s024ltr.pdf) | `989bb8b2d08f8ee47a1fccb7fe714e9b3074e72ffbdb7c833edf1720c28f0d30` | | 2019-06-14 | Supplement 21 · AP | Manufacturing (CMC)-Packaging | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022074Orig1s021ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022074Orig1s021lbl.pdf) | `109cac09ac7489dcdd611978b4bcb6ca98853c1aa4363bcf9d43ec3b26912bd2` | | 2023-02-24 | Supplement 26 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022074s026lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022074Orig1s026ltr.pdf) | `1e9f5c0f1d64aff5035503cd69501f21f5ad294b76c04965520e6637190f4d05` | | 2024-07-11 | Supplement 32 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022074Orig1s032ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022074s032lbl.pdf) | `646e545e8c7f1eba4379b56262aa0d09ea02a29be150f00e8da282fedd96f005` | ## NDA022200 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda022200/ - Profiles: Exenatide - Submissions: 31; documents: 47 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2012-01-27 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022200Orig1s000_corrected_ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200Orig1s000lbledt.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000TOC.html), [Summary Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf) | `1af0a07a35534279114119cb136c127facf58db2ef4e7d321b855f932ba4c012` | | 2013-02-27 | Supplement 5 · AP | Manufacturing (CMC) | None listed | `249088fecd601d81c07cdfa8fea903727f6e404f7956f88cfc353e704b3a5154` | | 2013-06-12 | Supplement 4 · AP | Manufacturing (CMC) | None listed | `4774adf4da612e3fccd6587a0b0815e8d4f77f17772d212f720b8d8f2febde81` | | 2014-02-28 | Supplement 7 · AP | Labeling-Proprietary Name Change | None listed | `607090b12e53e2cd58f12cfc633d780df17c515ab72a0e928c56d153d9396cca` | | 2014-02-28 | Supplement 8 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s008lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022200Orig1s008.pdf) | `9f3c6e5865842602b91c25d3de3f63d222262f1be8de7a38b1c19e28f9461599` | | 2014-03-24 | Supplement 9 · AP | Manufacturing (CMC) | None listed | `a432c684906bdbab8f4656df8aa41c5155d7a166791b74ce4050f42e45b6d1aa` | | 2014-05-22 | Supplement 12 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf) | `8a41e46ddf9bed90816b867573b1aac8fa2d6008adcad1a3de0ac8f8b1f32324` | | 2014-05-22 | Supplement 13 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf) | `7b9a1a69c3ede114d91d3b6283a6e8dad53e86cba72c4a1724d4dd6b2b53ed3f` | | 2015-03-05 | Supplement 14 · AP | Manufacturing (CMC) | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s014lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s014ltr.pdf) | `539a56aea20146b04ff78266f68a79b0944342b164b955b95f7413a7432eb127` | | 2015-03-09 | Supplement 19 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s019ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s019lbl.pdf) | `cbcb32eb039e13fc9e99d09863d3dbf043795c0b357db21671f77e0965abaf78` | | 2015-04-29 | Supplement 10 · AP | REMS-Assessment, REMS-Modified | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s010ltr.pdf) | `7baaa8ccf451768013ee7fa7c3384490fccbf331cd223c347c809480d7f4ccd5` | | 2015-08-14 | Supplement 11 · AP | Manufacturing (CMC) | None listed | `5118b5f61cb0fe2610fc121f68e3e4dff33e92af0fc50707794057d12bbd6283` | | 2015-09-18 | Supplement 20 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s020ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s020lbl.pdf) | `176966ee94757abfadfe9f65a6bc615c653c1ae6a591abb90b3bbd87c7f0c874` | | 2015-09-24 | Supplement 15 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf) | `97af8462c69c4e9f7cab1fd289487cfbd71effb3eca0e21fffcf66299af863cc` | | 2015-09-24 | Supplement 16 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf) | `0054a6800d61daa7940e52dbcc1c71203d5a5d4e472be63396a73c3180143b44` | | 2015-09-24 | Supplement 17 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf) | `68022dfa56d6dc29dbdb326da522e1209e61ac619977b3e9f07f7b2f817d4cd6` | | 2015-09-24 | Supplement 18 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf) | `e4747fd21cb5587bf5a962addf5ba4b174205de6653f0c8f49acfbfddcac4796` | | 2015-12-23 | Supplement 22 · AP | Manufacturing (CMC) | None listed | `5118b51648c6a58f534fe426ee0d88e80fbcd5c433b0563d91450dbbb68ddcc6` | | 2015-12-31 | Supplement 21 · AP | Manufacturing (CMC) | None listed | `a23e48bdcdcf2725b60717e76bd83bb7399bc012f381e75cb3e7d4e68b61a30e` | | 2016-01-11 | Supplement 23 · AP | Manufacturing (CMC) | None listed | `723a75de164aa96ea96eaa04d00c77410142d53f47239adb0b8632b0c39c5cb4` | | 2016-06-10 | Supplement 24 · AP | Manufacturing (CMC) | None listed | `ffb4cf9d744eaa7466d243dde22ba3067a3b003db7edbfde864e5c375289859a` | | 2017-10-20 | Supplement 25 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022200Orig1s025ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022200s025lbl.pdf) | `36fbad9ae22fcae8c9cd8f56a6f564661d652b97e265505e232120ab28f91877` | | 2018-04-02 | Supplement 26 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022200s026ltr.pdf) | `958be534149c568aa90e0260d6ced844a35970ce449d90656c518123a9da788a` | | 2019-02-15 | Supplement 28 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022200s028lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022200Orig1s028ltr.pdf) | `796b8cc024104dff3ad78b3a9940ae6713c7e88a562e1b08da02d2af5a3fb6ad` | | 2020-02-28 | Supplement 30 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022200s030lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022200Orig1s030ltr.pdf) | `929558884bf2bef414cb9cdc854f3c30a9cb44fcc5e3aa2ba3e45819b8e49093` | | 2021-07-22 | Supplement 31 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022200s031lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022200Orig1s031ltr.pdf) | `bccb6449d0466200b98488d857f12c58a60b86de2049a573fe63289fcf13042e` | | 2022-06-10 | Supplement 33 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022200Orig1s033ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s033lbl.pdf) | `d526d3f96cd25b7690d695c319c02cb8b393e68bca330e3f4c3148e2ffcac778` | | 2022-07-26 | Supplement 32 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022200Orig1s032ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s032lbl.pdf) | `1620307ce32aa875cd2d0ec7ba6c4632c60354d2921f4d6f2b830b8c741bbeb2` | | 2022-12-21 | Supplement 34 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022200Orig1s034ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf) | `7e1b8ba7761ec8a58ba506c6c2c72bd042e9fe994e3e5038167981080d45d138` | | 2024-11-01 | Supplement 35 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022200s035lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022200Orig1s035ltr.pdf) | `d86cf05e2f0238e327f8de1ac138fa6583019e3dd28946238da4a03e09d6d4ce` | | 2025-05-28 | Supplement 36 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022200Orig1s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022200s036lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022200s036lbl.pdf#page=38) | `e3d50fbc1c980af2e40fe57a700e01fd6cc08548a07b2aeb524f46c08286c299` | ## NDA022341 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda022341/ - Profiles: Liraglutide - Submissions: 29; documents: 52 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2010-01-25 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022341s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022341s000TOC.html) | `f74efea775af5bd0c5eae39733bbd812d151170c465640fc176fcf12c8f8133b` | | 2010-12-22 | Supplement 1 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s001lbl.pdf) | `67c7486422c742d6f5d952fc78a7af752983b80aaa645421cdbb2fbb8d1d3c48` | | 2011-05-18 | Supplement 4 · AP | Labeling-Package Insert, REMS-Modified | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022341Orig1s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004lbl.pdf) | `c86966ce28910f2b3ef8eb229ebb5dd44a95599fdb03e01968443ed79f087f87` | | 2012-04-06 | Supplement 7 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf) | `dbaeb1144b68c6fb249e09322c03678b3dad8b3272ac223fcb91ca4c50302982` | | 2012-04-06 | Supplement 9 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf) | `f84fd247897138652905332d5221495e7ca9235dc661e86616e028e3918dff74` | | 2012-04-06 | Supplement 13 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf) | `8b9c5b1bdd352ff50d493a9ffced865e7222fc917d246e6c956fcb916429d04a` | | 2012-12-03 | Supplement 10 · AP | Manufacturing (CMC) | None listed | `1026f504a397c37c457279342814426d4393d6fbee3aa34c7ed6543e68dbbeb5` | | 2012-12-13 | Supplement 17 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s017lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341Orig1s017ltr.pdf) | `96de4921ee6e68ac0d603969b347fca4ba03ea27d9b07a3783978139146d8cca` | | 2013-04-16 | Supplement 18 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s018ltr.pdf) | `bb70d8a378961e405cbaeff02de3b77c5c5075d30f225361f8b0a75f4e2385e8` | | 2013-06-13 | Supplement 20 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s020ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s020lbl.pdf) | `bb9b79ebcb2281531397e7f3d463b6fa99c4ded8e2d6c8639a9a231f50dc68e0` | | 2014-07-31 | Supplement 21 · AP | REMS-Modified | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022341Orig1s021ltr.pdf) | `7865bcb9c81b9ad96a23d36906e8db112cca32bb27bb8c48ca620535bf103d45` | | 2015-02-25 | Supplement 22 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s022ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s022lbl.pdf) | `304133e494442661a63ee430e9ee433ee7653621723ccd9183d9af6aecf29a48` | | 2015-03-09 | Supplement 23 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s023ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s023lbl.pdf) | `e1e53db88f75beb06fc618b8a96d105f0aee6708bb67b40b6608912f06d6886b` | | 2015-07-01 | Supplement 24 · AP | REMS-Modified | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s024ltr.pdf) | `b6d3ca19a81fba483fbbf27367bdd455e957ab8658681b902e2eecc37cdcbe16` | | 2016-04-22 | Supplement 25 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s025ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022341s025lbl.pdf) | `61343c0101f745f797791a5bd0c078136c67b6db5e5cdaae520fbfb1068fc976` | | 2016-09-20 | Supplement 26 · AP | REMS-Modified | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s026ltr.pdf) | `9baa5ed7c5f1cdeaf1f4039cbaec45e3e28beeb42dbd24e4f6dc9a3de4292cbf` | | 2017-04-25 | Supplement 28 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s028lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s028ltr.pdf) | `14ad4a355a345fc915d5950e2661da46ba3c9b3c2e81133f391df2448f9a285a` | | 2017-07-26 | Supplement 29 · AP | REMS - MODIFIED - D-N-A | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s029ltr.pdf) | `592536451f149ce37c2bb414d8697275ffb0bd69202ee8cc5f6736c459e4a021` | | 2017-08-25 | Supplement 27 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s027ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s027lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/022341Orig1s027.pdf) | `35795583da3b96eed219b349674e31b5532e3032cf05ba7fa6ef4dd577267616` | | 2019-06-17 | Supplement 31 · AP | Efficacy-New Patient Population | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022341Orig1s031ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022341s031lbl.pdf) | `70cbfd7db94d2d796e205df103ea282352b37e2eb142606070dc7366eab29220` | | 2020-08-05 | Supplement 35 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s035lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022341Orig1s035ltr.pdf) | `244e0cb7d05840063ba2c10574ca6b1f1c8b3915dcce891733e522ba49e7242f` | | 2020-11-20 | Supplement 36 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022341Orig1s036ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s036lbl.pdf) | `33c9e35baae9daf9a9da15f344484f9d0b9751d1673a8ca55982b3706bb62ba1` | | 2022-06-10 | Supplement 37 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022341Orig1s037,%20s038ltr.pdf) | `37bcdafaa64e43bc894ef59f38f6fe2380cf8d82943893961fe6cf782254c10b` | | 2022-06-10 | Supplement 38 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022341Orig1s037,%20s038ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022341s037s038lbl.pdf) | `7dba280d9ff1a26baec7ff65ed1747a9c2b9fcc7fe8fdd39be307155a795ff00` | | 2023-07-05 | Supplement 39 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022341s039lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022341Orig1s039ltr.pdf) | `1430146ee5e0fba8b21890ce87e37585df4e2d9d8cd765ad3c48f16fd50413c7` | | 2024-11-01 | Supplement 43 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022341Orig1s043lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022341Orig1s043ltr.pdf) | `dc2152044f606f3f0b358d1a05ccd429d6ddc8b33b1603781d3ade10e8807c24` | | 2025-02-12 | Supplement 42 · AP | Labeling-Container/Carton Labels, Labeling-Patient Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022341Orig1s042ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022341Orig1s042lbl.pdf) | `1635c935d0c0a1015d00315a266d01d9ee64b1744859e3e68f4a76d8c42d3fc4` | | 2025-05-28 | Supplement 44 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022341s044lbl.pdf) | `e1aa02abd0b44e8298d0c81e486a31555569e3e4a7b66c6f8008347b0fe60985` | | 2025-10-14 | Supplement 46 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022341Orig1s046ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022341s046lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022341s046lbl.pdf#page=32) | `7651f0444bbf6de38d84bf9ca5a5144e61d428b08a9d844ecb9ff2cfd145264e` | ## NDA201849 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda201849/ - Profiles: Glucagon - Submissions: 8; documents: 12 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2015-05-08 | Original submission 1 · AP | None listed | [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201849Orig1s000TOC.html), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s000ltr.pdf) | `c1e6c28248721dd158cb4fdc00fc2d1fd1912b1fe016fea7b23bdfe920bb2d1d` | | 2015-11-03 | Supplement 1 · AP | Manufacturing (CMC) | None listed | `c01483836272e4289611750ee57c31beb8b39050a136971635f93686e5b783d7` | | 2015-11-03 | Supplement 3 · AP | Manufacturing (CMC) | None listed | `7abc092f81d892e03deab50f3ec28973b393a2802d7cacbb96d992e4742fe1dd` | | 2015-12-01 | Supplement 2 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s002ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201849s002lbl.pdf) | `d30895b9f2cd72b98116ba4e7bffd3b6861fcaea5573955bc600e1d74445e667` | | 2019-09-09 | Supplement 5 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201849Orig1s005ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201849s005lbl.pdf) | `ea1c8c8ac76a2e8557f34adbd052fc1defac51ef01d5b7b3042572d310e348b8` | | 2021-07-29 | Supplement 9 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201849Orig1s009ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201849s009lbl.pdf) | `65468226009aa0639a0bac37a7c97fd27e1bf634e5bb8ed66625148d88cb5ea3` | | 2022-07-14 | Supplement 13 · AP | Labeling-Package Insert, Labeling-Patient Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201849Orig1s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201849s013lbl.pdf) | `61bfdb4b3517e02c212627b308b8b40fa751103928be8f165f85dc2c5e5ca486` | | 2025-07-30 | Supplement 24 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/201849Orig1s024lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/201849Orig1s024ltr.pdf) | `3167a28b0b0c8c99d4406496bb5ca3968438347b9281be03a2df4b2f8f521352` | ## NDA202811 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda202811/ - Profiles: Linaclotide - Submissions: 20; documents: 33 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2012-08-30 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202811s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202811Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000TOC.html), [Summary Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000SumR.pdf) | `0bf54061062d62ea6cb2dd67848a269213dc5c55a1e9aa8c302f1256b8627693` | | 2013-08-08 | Supplement 3 · AP | Labeling-Medication Guide | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202811Orig1s003ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202811s003lbl.pdf) | `d0d2012640f24d61337afc2e84d4f92aa8e68aa08e74a2373ac6312c3799aad1` | | 2013-11-08 | Supplement 2 · AP | Manufacturing (CMC) | None listed | `d0a13552beaae1efebd9144bfe0cba06b49c463e7f6366145bae7614ccf8b3b9` | | 2014-07-01 | Supplement 5 · AP | Manufacturing (CMC) | None listed | `8e899bec49b87b426fc3c2367a933498ac69c6ec96eaca25665b5d82374f52e2` | | 2014-07-09 | Supplement 4 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202811Orig1s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202811s004lbl.pdf) | `09924b65b90bc7e63584a589edaf683a7035d330c05270ad592d7f15c4cd33e7` | | 2014-12-11 | Supplement 1 · AP | Manufacturing (CMC) | None listed | `230ddd1729a4df88977e230babd1e6a47e49f035c98fc2344703301d79d36a8e` | | 2015-01-05 | Supplement 6 · AP | Manufacturing (CMC) | None listed | `e75789f9a42e258b1389cb684ce6d23ed10dc9ac5c12abef6c75e17f4ad6de85` | | 2015-11-23 | Supplement 9 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202811s009lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202811Orig1s009ltr.pdf) | `db3e1b06712f2382c4cdda1d4cb35464204adb899096e2b083fc0460e6553a4a` | | 2016-04-06 | Supplement 7 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202811Orig1s007ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s007lbl.pdf) | `ce8c8ef9878b5a6ae400f95fd51406397cd5459846dadd0ade010e53c9636e9a` | | 2016-05-18 | Supplement 8 · AP | Manufacturing (CMC) | None listed | `a61cde27e0460331f500b1156d60fd27758fd02d08ed6c727b1a3a655dfc9bff` | | 2016-08-31 | Supplement 11 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202811Orig1s011ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s011lbl.pdf) | `0f5d9ea8c3bdbadb4e0eea4af862b7c00291f94d2653e2891e61234ef1265d40` | | 2017-01-06 | Supplement 12 · AP | Manufacturing (CMC) | None listed | `5bf35e674f0c83d54530fbcae7dc40b6ee0912febe0894e99a1bb488e5e09a3b` | | 2017-01-25 | Supplement 10 · AP | Efficacy-New Dosing Regimen | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s010lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202811Orig1s010ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/202811Orig1s010.pdf) | `505a964f9a9ba73d7c3c9bb7cff7cc7d0713cfaf7ccbe99ecbed561a3ae88a35` | | 2017-03-08 | Supplement 13 · AP | Labeling-Package Insert, Labeling-Patient Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202811Orig1s013ltr.pdf) | `bd637a316a1432c2385990a7e0d0e64475650bfbc97bd44bd1b410b629ae5499` | | 2020-09-22 | Supplement 16 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202811Orig1s016ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202811s016lbl.pdf) | `2455de4a522dc9c22ab5749527bef34f890c931086d283d609e5933ba741c9d0` | | 2021-04-12 | Supplement 17 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202811Orig1s017ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s017lbl.pdf) | `fdc7a1e540dc2e5ed6d1414482102fba865beb57a5811d08a370b69579388400` | | 2021-08-24 | Supplement 18 · AP | Labeling-Medication Guide, Labeling-Patient Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202811Orig1s018ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s018lbl.pdf) | `01bd0def7fc35f03bd9c149166169c85162dbf02ac382ebbf50ac95f494b6edc` | | 2023-06-12 | Supplement 21 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202811Orig1s021ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202811s021lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202811s021lbl.pdf#page=23) | `d68c391bf3112a93fd7d45e5c2fce85ce00d5e8ffbedc595cacc57ad2b024a00` | | 2025-11-04 | Supplement 22 · AP | Efficacy-New Patient Population | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202811s022lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202811s022lbl.pdf#page=26), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202811Orig1s022ltr.pdf) | `e67974a240988347ae28eb06a5c852e41f8cec7e9ceb46f644deff3645797806` | | 2026-05-21 | Supplement 23 · AP | Efficacy-New Patient Population | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202811s023lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202811Orig1s023ltr.pdf) | `b0f393762b8397c03962783204adc582ef8b86db63237309d9dcfbbbe8d9aea3` | ## NDA205054 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda205054/ - Profiles: Leuprolide - Submissions: 5; documents: 11 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2018-08-28 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205054Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205054s000lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/205054Orig1s000TOC.html) | `5629e37c743c83488cdac4f19f6d2b35af367622b474ebc27177b88324d8fd32` | | 2023-02-28 | Supplement 4 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205054Orig1s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205054s004lbl.pdf) | `96a69be62b768bed85ca409ce341b05d01d25a13ef676c9b9beab819051e8c6b` | | 2023-11-30 | Supplement 5 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205054s005lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205054Orig1s005ltr.pdf) | `c6e32f63da6372a8118eec922b9c4b23f1043b4b5560aa90e0b5647ccb325356` | | 2024-08-08 | Supplement 6 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205054Orig1s006ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205054s006lbl.pdf) | `bc4e0d6296a14d34912b42f0de1092f5ee9f0729577f03bfc0cd5a8a8d8b494a` | | 2024-11-14 | Supplement 7 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205054s007lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205054Orig1s007ltr.pdf) | `a502769ea16f4dca1a59695b531bdffc8660a88587ab4850e5d40afd9b33d2d9` | ## NDA206321 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda206321/ - Profiles: Liraglutide - Submissions: 20; documents: 40 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2014-12-23 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206321Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206321Orig1s000lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206321Orig1s000TOC.html) | `dc80c37614e91c20cae35876cf81d48d45626098314bacd3f8efcf0aeedb1d9e` | | 2015-03-27 | Supplement 1 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206321s001lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206321Orig1s001ltr.pdf) | `048945cea167f3d07991adbc69d5675bd179dabfe0f453d0d8ad27935735de2b` | | 2016-02-01 | Supplement 2 · AP | REMS-Modified | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s002ltr.pdf) | `1003d6380e1bc37e7b89706eb696c3e6f403b8fbce4773b69b75dbf93427c147` | | 2016-09-22 | Supplement 3 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206321s003lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206321Orig1s003ltr.pdf) | `1b825b15e40dff5f370b9e2a78398289060d34c8f64b73d4854adc474e32f8ff` | | 2017-04-26 | Supplement 4 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s004,s006ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/206321Orig1s004.pdf) | `53b7818dcd80b40bb369829d019e89619aec2ae1fcbc287d4607111c528bef23` | | 2017-04-26 | Supplement 6 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s004,s006ltr.pdf) | `40bede966118df5bd4ad24f2e7d088429ebdf2e25ef2dcd651c3d08d55f02905` | | 2017-05-22 | Supplement 5 · AP | REMS - MODIFIED - D-N-A | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206321Orig1s005ltredt.pdf) | `dd2876667bf9e263411aef3cca224515d51ac1a53aab0d7f6be84e11869e219f` | | 2018-10-19 | Supplement 7 · AP | Efficacy | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206321s007lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206321Orig1s007ltr.pdf) | `6754548d73c0393a503e567f782eabacaa8aa5b308391e8cf620b23dafeffc43` | | 2018-12-04 | Supplement 9 · AP | REMS - MODIFIED - D-N-A | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206321s009ltr.pdf) | `51b0366ca12d743a84775c6b7aad3f0141134b73b5cb3a97703f3c2fdbc61527` | | 2020-03-25 | Supplement 11 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s011lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206321Orig1s011ltr.pdf) | `58f3902fd19f7c99e725ddb85584f2403d8bcd113156fc2e47769579cdbec431` | | 2020-12-04 | Supplement 12 · AP | Efficacy-New Patient Population | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206321Orig1s012,%20s013,%20s014ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf) | `a266e5f06937e268c6ec34727ed2a85ace86025089bfc2bdba684dfe9431d02d` | | 2020-12-04 | Supplement 13 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206321Orig1s012,%20s013,%20s014ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf) | `704d2379ecba69a5c4f777be229bf5272c6fac08b44b69986c237a580f9133da` | | 2020-12-04 | Supplement 14 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206321Orig1s012,%20s013,%20s014ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s012s013s014lbl.pdf) | `078c8328cc07dd171fccb48984fe5042c35fab9796570209e2a69de5417f64fe` | | 2022-06-15 | Supplement 15 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206321Orig1s015ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206321s015lbl.pdf) | `3223a81f8dad0711c7ab0008b7b77119bf71181ed4910a517591c915f47a01cf` | | 2023-04-20 | Supplement 16 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206321Orig1s016ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206321s016lbl.pdf) | `1c42e6245ce4d13a26daaf7e58bf36acc9204fc1000fa32adae082b22b851f0c` | | 2024-11-01 | Supplement 19 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206321s019lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206321Orig1s019ltr.pdf) | `635a418810cc499336c0708d8d4751eb1ebf1d70c1768c54d042c649a57709f9` | | 2025-05-28 | Supplement 20 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/206321Orig1s020ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206321s020lbl.pdf) | `a6046fba91acb37b51b5eb99c902fc2767ea68dd10accc98ceae52206729af55` | | 2025-10-14 | Supplement 22 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/206321Orig1s022ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206321s022lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206321s022lbl.pdf#page=29) | `86a00667564eba4f992e8f7e908f7447e0b3b267fb11d33dbecea69df13df47c` | | 2026-02-25 | Supplement 25 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/206321Orig1s025ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321s025lbl.pdf) | `8ee4df25cbcd0d8915a1d54a32f469f3aeaa841cc84f4f20d514465d56d63d3e` | | 2026-06-02 | Supplement 24 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/206321Orig1s024ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206321Orig1s024lbl.pdf) | `e895cf6f23afad7368608feff87e62620fd9c49b37cf9faa913479866053ea61` | ## NDA208232 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda208232/ - Profiles: Octreotide - Submissions: 2; documents: 5 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2020-06-26 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208232Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208232s000lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/208232Orig1s000TOC.html) | `c6d2babbc6364533061383c9fbc89a48ffa44ab022313be4fb93f8ab834ea0c7` | | 2024-07-11 | Supplement 6 · AP | Labeling-Package Insert, Labeling-Patient Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208232Orig1s006ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208232s006lbl.pdf) | `97e9658d9b393c0d59ab35223108695ab918fd9ff74e2c68234668324b349f9b` | ## NDA208743 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda208743/ - Profiles: Abaloparatide - Submissions: 11; documents: 23 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2017-04-28 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208743Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000TOC.html), [Summary Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000SumR.pdf) | `53655b7eeb5e4aab80b6ec9504ac2b80589ee97fa6e16dd7bc9dead451a86e78` | | 2018-02-05 | Supplement 1 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s001lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s001ltr.pdf) | `df68fc678b573811040de3134273d7936202d860f8b352713a923f9ea746eec5` | | 2018-06-20 | Supplement 4 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s004lbl.pdf) | `0fa2e4a5cc2d2126f1ec7771f8bdedebcf84fbad49130a773da7c86506fe6726` | | 2018-10-17 | Supplement 3 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208743s003lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208743Orig1s003ltr.pdf) | `97f8b3b5bc25cc6e54e303a303253a7a3f7618745dbf0612596fbaf1ff314499` | | 2020-10-23 | Supplement 7 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208743Orig1s007ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208743s007lbl.pdf) | `d46c740d03e1ad3d2ac09d6c7e6667a940ec8a9ae0481725999629178b87c7fe` | | 2021-09-20 | Supplement 9 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s009lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208743Orig1s009ltr.pdf) | `99fca8ad6e52310fe3515d82016976243f6e31aaf5efe236b52fdb6ef7e78aa8` | | 2021-12-22 | Supplement 10 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s010lbl.pdf) | `e113ae0b683c7395551045a9c25593b9758a706587d24ed8392a1ad29714ab2b` | | 2022-12-19 | Supplement 13 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208743s013lbl.pdf) | `5805a3458d46ad8a17166e4392954cdd05eeb6ec8aee6a114b01e24be1cbeadc` | | 2023-12-21 | Supplement 15 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208743Orig1s015ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208743Orig1s015lbl.pdf) | `70edac73a6293d3ec9ac92b2817d0895681529bb735a388544cc3d652a05477b` | | 2025-03-28 | Supplement 17 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208743Orig1s017ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208743s017lbl.pdf) | `9e6fb90606e6ac47503cfa87d8a72301b3b4043278a800716641751b0088edd1` | | 2026-08-03 | Supplement 18 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208743Orig1s018ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208743s018lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208743s018lbl.pdf#page=22) | `853bd892393de3161adc7bcda24b76e56c3a2b6722371cf56bd4f38863609cc2` | ## NDA208745 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda208745/ - Profiles: Plecanatide - Submissions: 6; documents: 15 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2017-01-19 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208745lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208745Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208745Orig1s000TOC.html) | `3d3a01e08218fc68103c3bf2de486af1f43baf5623a27057d24f6d6d78f4b1e8` | | 2018-01-24 | Supplement 1 · AP | Efficacy-Manufacturing Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s001lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208745Orig1s001ltr.pdf) | `365b7f650b718637deeecd5e6d1c940f77f97d53bae71e8c36f13d7c8b319f35` | | 2018-07-25 | Supplement 2 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208745Orig1s002Ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s002lbl.pdf) | `29049fc2240530cfcc7ade963b3904ea2213b1b9f4ec0268a74de32a63101621` | | 2020-10-29 | Supplement 10 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208745Orig1s010ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208745s010lbl.pdf) | `30e86dedd7d502dbec5fbfa62b12bc27d295415ef1dcf19e0563cbd9a0f4050e` | | 2021-02-10 | Supplement 7 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208745Orig1s007ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s007lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s007lbl.pdf#page=15) | `31711945f6c67512e41ce4ea0cd794b413c2e1299356cf5d2efcc9b7af811ed9` | | 2021-04-13 | Supplement 11 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208745Orig1s011ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s011lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s011lbl.pdf#page=15) | `4d032f5d8501f4a0cc286f0127e431ad2fd2876c0288659fe53ec17b35a65304` | ## NDA209210 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda209210/ - Profiles: Exenatide - Submissions: 18; documents: 39 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2017-10-20 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209210s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209210Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209210Orig1s000TOC.html) | `3c30d5a80972d75ecae6f153f078b5277aed630fe0815fc1a316c19d43407ade` | | 2019-02-15 | Supplement 1 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s001lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s001ltr.pdf) | `ead69cefb12b06b3950b5839e5943292d58cd0fd7a69fff05ce0c8836829ad22` | | 2019-07-25 | Supplement 2 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf) | `0aad4a5423c9b8422af1992c4e49e0993bfc601a3c546ec2e6c87540599718c5` | | 2019-07-25 | Supplement 3 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf) | `280e1840dca9e670572345effef107f1c5e0b8f15508e6a24c2501056ac6ce4d` | | 2019-07-25 | Supplement 4 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf) | `53a2ee252c418027b1d9a37cc323e799fc6d4e4e03f399dd15b406ce0e1a10c4` | | 2019-07-25 | Supplement 5 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf) | `b12698573a436331e62a31a09da2639fd6f7e9c00d59a4a91b9432a2ce9a5c59` | | 2019-07-25 | Supplement 6 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf) | `5eee47b97eef22408da48104376482948e7b9a6a85d1207701d603dc8afbaae8` | | 2019-07-25 | Supplement 7 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf) | `0a7366f31eed33e94d1c344689b89a6cf55b97ffa0663bca5789890ea522a70c` | | 2019-07-25 | Supplement 8 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf) | `98b92c96b7530f5117dd26798cde3aa8c018a97eb03e2abe03893c9f6affdff9` | | 2020-02-28 | Supplement 11 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s011lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209210Orig1s011ltr.pdf) | `1dc373846353ae2a0b75e880976cf3e4a18b1b92d2cce5befabfd3a28d2e40f9` | | 2020-12-02 | Supplement 14 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s014lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209210Orig1s014ltr.pdf) | `6aa3df35476837a751827e7da1f2bcca8587fef37abfacabf8b2fb1d9cacdac1` | | 2021-07-22 | Supplement 17 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209210s017lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209210Orig1s017ltr.pdf) | `8816b195e5ec8699d53deafde51ba3f1d6be403f6a638bdd2b719a9d18f93644` | | 2022-06-10 | Supplement 21 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209210Orig1s021ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s021lbl.pdf) | `913970b54dd01ead72371b6160e4cd229d4410432c5b6b64d13323d79830cf0b` | | 2022-07-26 | Supplement 19 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209210Orig1s019ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s019lbl.pdf) | `d0f084e10e01eb70b3bc30d97202199c46e0162a4807b8824cb61f5bc8600ebd` | | 2022-12-21 | Supplement 22 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209210Orig1s022ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s022lbl.pdf) | `565d37f4aff0fb83b3eaa353296e8f927b36ebe6dca91df4c9d9c3e8085c2520` | | 2024-03-06 | Supplement 23 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209210s023lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209210Orig1s023ltr.pdf) | `61371a4dc80238333b2480fde98ccfc1de6e8fd7aa1bc6d3969148b95cc49dc4` | | 2024-11-01 | Supplement 24 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209210s024lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209210s024lbl.pdf#page=37), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209210Orig1s024ltr.pdf) | `143c4479da17865fb4adbebc695cbd7d577e494177701e7694f7df63ddfca5d3` | | 2025-05-28 | Supplement 25 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209210Orig1s025ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209210s025lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209210s025lbl.pdf#page=37) | `08c2c38be1e8a2cbba8b4b790c5cab168e2b08a9736a2518a5618cb320cbd22a` | ## NDA209637 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda209637/ - Profiles: Semaglutide - Submissions: 14; documents: 33 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2017-12-05 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209637s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209637Orig1s000TOC.html) | `d958c2d07c8846fd9f2861473c0c6f2646885cbd7c83d8f7bcf4db01b7d7831f` | | 2019-04-09 | Supplement 1 · AP | Labeling-Container/Carton Labels | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s001lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209637Orig1s001ltr.pdf) | `6aace614b3b7173218db05a3eae9f14105a4fa01bd4878e559366a662c19434a` | | 2019-11-27 | Supplement 4 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209637Orig1s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf) | `8105b92b4856857723b5043d3a0ba7494b8f509ad04e3e6421720bf6626b5204` | | 2020-01-16 | Supplement 3 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209637Orig1s003ltr.pdf) | `73c9126328ea7f76000239cab4f45c639a5b31e7f3a8bf0d0329ebb9d6565d0a` | | 2021-04-12 | Supplement 8 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209637Orig1s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209637s008lbl.pdf) | `8395306212eba2c82d2337e594d86fef98e1f8585cf8df889e176e303361b4f0` | | 2022-03-28 | Supplement 9 · AP | Efficacy-New Dosing Regimen | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209637Orig1s009ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637Orig1s009lbl.pdf) | `5124ee3316950d632ca285d1d502991f077d3e62bcb55cfd877c7ef9ba4a8a97` | | 2022-10-06 | Supplement 12 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209637Orig1s012ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s012lbl.pdf) | `be4150a714fc952bf7cdfa8fc973527a75081a2ff68b1de75972d5d95e00968b` | | 2023-09-22 | Supplement 20 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209637Orig1s020,s021ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209637s020s021lbl.pdf) | `f86c71713576892cb0e0e7fd1355b11c3a5441bc617760b021c992575d6a5d10` | | 2023-09-22 | Supplement 21 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209637Orig1s020,s021ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209637s020s021lbl.pdf) | `bf585abc00ab9f38f30f92edb4fc8f0e907711a410126fa00b309e34cf15e9fb` | | 2024-11-01 | Supplement 32 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209637Orig1s032ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209637s032lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/209637Orig1s032.pdf) | `eb15a463bec512a7a9f21ca129e6f7d921bde4eb171a898c70b3c720cc84ee03` | | 2025-01-28 | Supplement 25 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209637s025lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209637Orig1s025ltr.pdf) | `96a2f0cb355fc89e27c195a00add8cf15403804e207632197331a3a13d059d2b` | | 2025-10-14 | Supplement 35 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209637Orig1s035,s037ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209637s035,209637s037lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/209637Orig1s035.pdf) | `74679697fb5b569a1c8468530a469a7eecbf1e314cc496a78f47372f0550edd2` | | 2025-10-14 | Supplement 37 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209637Orig1s035,s037ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209637s035,209637s037lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209637s035,209637s037lbl.pdf#page=31), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/209637Orig1s037.pdf) | `cba164cad342be5f3965f77c2e25347b67ee80e3991492cbe90bd848f6713a0a` | | 2026-06-01 | Supplement 38 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/209637Orig1s038ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf) | `c3ef460887e7d3856b029c1cdce4494608e21c0bf1ad16529a9bc1f67acf108b` | ## NDA210134 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda210134/ - Profiles: Glucagon - Submissions: 3; documents: 7 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2019-07-24 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210134s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210134Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210134Orig1s000TOC.html) | `ed3e3f2bc0d0d22e9d8f168bf2390af7b06cb5c2744720404cf9e1c269d6d023` | | 2020-10-27 | Supplement 2 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210134s002lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210134Orig1s002ltr.pdf) | `3813f536a0f3a537cfeb33566004ac1c61ab99268aee62c080e48e0c03fcd2b0` | | 2025-03-17 | Supplement 4 · AP | Efficacy-New Patient Population | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210134s004lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210134Orig1s004ltr.pdf) | `c43f1bcb838a52bb9f268945381c6ec50577e8ad1763690ea46aa713cb6ecf45` | ## NDA210557 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda210557/ - Profiles: Bremelanotide - Submissions: 2; documents: 5 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2019-06-21 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210557Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000TOC.html) | `d0128d66ba9140fe05c8f25216581816e0274dbf8ae9d593850322a656688db0` | | 2020-10-23 | Supplement 2 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210557Orig1s002ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf) | `1794eed4fa3889bd0a8741f86fe35655bc4e78a6b840f06a1e2613549c646eb5` | ## NDA210797 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda210797/ - Profiles: Afamelanotide - Submissions: 2; documents: 5 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2019-10-08 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210797Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210797s000lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000TOC.html) | `2c5f04be8c330037cd17eb2fd8ce9675ab750d578af60162a34dfc6b2ea4f278` | | 2024-08-12 | Supplement 7 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210797Orig1s007ltr.pdf) | `6ab80a676a3823800ba87aa87dac20fa3aa31708ef0da692cb7d37b13e63a34a` | ## NDA211939 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda211939/ - Profiles: Teriparatide - Submissions: 4; documents: 10 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2019-10-04 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211939s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211939Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211939Orig1s000TOC.html) | `42579d6fabe1552775c1d8a486537dbeab540a281d99151189e1d5fa2e1e2ce3` | | 2023-11-16 | Supplement 4 · AP | Efficacy-Labeling Change With Clinical Data | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211939s004lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211939Orig1s004ltr.pdf) | `87a45084ac196aab0f98c110d998acb404eb76ee81ff99f80e21a49acc979df8` | | 2025-01-24 | Supplement 17 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211939Orig1s017lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211939Orig1s017ltr.pdf) | `b80180878b61c550886cf9bcc940d46d7d436d777dc1923bf518b727350c9a05` | | 2026-08-03 | Supplement 21 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/211939Orig1s021ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211939s021lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211939s021lbl.pdf#page=22) | `61cb285eb23cc3eb66c1c2f6cd5d922d6eb2c290070b358a59e116f317680f33` | ## NDA212097 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda212097/ - Profiles: Glucagon - Submissions: 6; documents: 12 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2019-09-10 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212097Orig1s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212097Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212097Orig1s000TOC.html) | `49fbc3bd2de704d97c6d925f0a3b6bcd3a39b46cef8ed85cb9d13fba87c25940` | | 2020-04-07 | Supplement 1 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212097Orig1s001ltr.pdf) | `d21e36da4d8a9cf87ab8509d757576738266402a04c534bd3fafba6ec55b829d` | | 2021-07-15 | Supplement 8 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212097Orig1s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212097s008lbl.pdf) | `9f0a294d8685808ff4bae0db0fc550388864fd3ef99dac6740fd016478f0f02c` | | 2021-08-20 | Supplement 7 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212097Orig1s007lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212097Orig1s007ltr.pdf) | `ed599ecd27088c9c5c41115e9cbf8ede13331a4308030fbbf9fdbf09f729118f` | | 2023-12-22 | Supplement 13 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212097Orig1s013ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212097Orig1s013lbl.pdf) | `b903d899bbd015211b13f12c2d6b343b7f43a771e3e14dca1a491982665d88e3` | | 2025-03-14 | Supplement 12 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212097Orig1s012ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212097s012lbl.pdf) | `f1bc701e7a58407e587cf2a84ec8e7145988a12747342ebd23d309ff22ff9c7a` | ## NDA213051 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda213051/ - Profiles: Semaglutide - Submissions: 13; documents: 28 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2019-09-20 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213051Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000TOC.html) | `0202eb15baea53065bc33bc7513fcc4c618a9e625ce1c067c747b2b72b0fccdc` | | 2020-01-16 | Supplement 1 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213182Orig1s000,%20213051Orig1s001ltr.pdf) | `d3ded611a967cac39fca9d786b0ba353432a17d5f7548927c27276d80cf5a3d8` | | 2021-04-30 | Supplement 6 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213051s006lbl.pdf) | `84b9a0b145c4cf6486c7685e0455398c9046c2f5d789965e8be8d45af8bf122f` | | 2022-06-10 | Supplement 11 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213051s011lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213051Orig1s011ltr.pdf) | `abea5ebc23a8a5a4dfc27c58a7f5a3ffb60fa667133b2760f98d40007c5ebdaf` | | 2023-01-12 | Supplement 12 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213051Orig1s012ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213051s012lbl.pdf) | `e60a14bdf78a4987a1144e0628623f4fc0c1c2a1ff6f1ffd1733c6bdc1c81e3e` | | 2024-01-24 | Supplement 18 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s018ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s018lbl.pdf) | `56789b4897caa06a18a8ec601250ee69b5a4c6e3d886af6e146a0bdba463d79c` | | 2024-11-01 | Supplement 23 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s023ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf) | `dc8ca2db8b83679b6eaa785d1ec401e7b8038b5568b3d6952efd46142c5496b3` | | 2024-12-09 | Supplement 20 · AP | Efficacy-New Dosing Regimen | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051Orig1s020,213051Orig1s021lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s020,213051Orig1s021ltr.pdf) | `f73d13d5d1e1b85d43777a0a7a350b9e7ef8e58f282784a940c44f14ef0e06a1` | | 2024-12-09 | Supplement 21 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051Orig1s020,213051Orig1s021lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s020,213051Orig1s021ltr.pdf) | `ed4cd82045194c6f22ff0bd99875c496c31dad03f3f377aee796a40f8ed25ee4` | | 2025-10-17 | Supplement 24 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf#page=27), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf) | `8ef3091aa3de364ca33c1c6ac70d31b190558a27df1e1387d33578e59e6ed30b` | | 2025-10-17 | Supplement 28 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf) | `74451adc3bfe79a52024735304633e876c9c8b86b3f3dbaa0eda39624c064193` | | 2025-10-17 | Supplement 29 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf) | `2296fad3fc0c7e8a339c6a7a0349f69770c135b63161b3bc396f80a216b25552` | | 2026-01-30 | Supplement 30 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213051Orig1s030ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.pdf) | `149623be3c3dc79d42d210afa1bccc30a391089ad1bf36a259d29b73ea65fae7` | ## NDA213150 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda213150/ - Profiles: Leuprolide - Submissions: 6; documents: 13 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2020-05-01 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213150s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213150Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213150Orig1s000TOC.html) | `2a3126ab4f0ac7d4214bc6ad8c1a6ef492774f09dc6eea91065ed10cf99a4aa4` | | 2022-04-22 | Supplement 2 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213150Orig1s002ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213150s002lbl.pdf) | `5d040676531f26882c750eb37299d5bd1bfaebc3c964eaec46ac1a0d0a051e0b` | | 2022-11-25 | Supplement 3 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213150s003lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213150Orig1s003ltr.pdf) | `9d871cd82b35c064d09777249f519047bb923e523af1c4a174b235d5a552b87a` | | 2024-10-17 | Supplement 4 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213150Orig1s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213150s004lbl.pdf) | `949b55c0a7b06565e46a4d779c4f61f6d9f1c956c808adffa0fb52b8ff0c4808` | | 2025-05-05 | Supplement 7 · AP | Labeling-Container/Carton Labels | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213150Orig1s007ltr.pdf) | `64551b353eea95a763f32d6ec8a4a0f710beb52981675d1ba0d7e929bd8401ee` | | 2025-09-23 | Supplement 11 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213150Orig1s011ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213150s011lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213150s011lbl.pdf#page=16) | `5d27a9c0f93784c7b710bfe90bee5b02949421888fa91ffc9225ec35602aa9d6` | ## NDA213182 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda213182/ - Profiles: Semaglutide - Submissions: 1; documents: 4 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2020-01-16 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf#page=23), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213182Orig1s000,%20213051Orig1s001ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213182Orig1s000TOC.html) | `ad72c3138fa77c1f694ba3125540a774c4fb11c3659d7c9b1758d6a06cb2a30c` | ## NDA213224 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda213224/ - Profiles: Octreotide - Submissions: 1; documents: 3 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2024-09-27 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213224Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213224s000lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/213224Orig1s000TOC.html) | `7995a21681d84616dbaa4e6d500f590dee7b024068f966a9223055c29801319d` | ## NDA213793 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda213793/ - Profiles: Setmelanotide - Submissions: 6; documents: 13 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2020-11-25 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213793Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213793Orig1s000RPLlbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213793Orig1s000TOC.html) | `3276861acf399ec7586b52a8c961b79e184d0c1d2aa94203cd144ee0af75bfd0` | | 2022-06-16 | Supplement 1 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213793s001lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213793Orig1s001ltr.pdf) | `786e5efbf3094e519b975eb02d5bef61ea6aedee363982e7ae4536c83e33ecea` | | 2023-11-15 | Supplement 5 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213793Orig1s005ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213793s005lbl.pdf) | `3508e3bea2b49fe6fa3539a84b552a661a19fa8070f02b88445f1f64b3b80d20` | | 2024-12-20 | Supplement 7 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213793s007lbledt.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213793Orig1s007Correctedltr.pdf) | `92d15798636d8db6dc4589d626af58fe2dc446440229901589c8287e53f46123` | | 2025-08-21 | Supplement 8 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213793Orig1s008lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213793Orig1s008ltr.pdf) | `6a04b57039f2562c60a951efcc47b7b00746b3ba14b1e4c9eb110a06ed172d98` | | 2026-03-19 | Supplement 9 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213793Orig1s009ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213793s009lbl.pdf) | `f6aa2558d94a8e7e0472303adb9536b870333a74a28bbb98fe709b6af8995476` | ## NDA214938 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda214938/ - Profiles: Vosoritide - Submissions: 3; documents: 8 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2021-11-19 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214938Orig1s000Corrected_lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214938Orig1s000Corrected_ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214938Orig1s000TOC.html) | `7f71c392e84284e671973178d3e5bc3b7615e696fac2f207ac39eb0d583ad2c4` | | 2023-10-20 | Supplement 2 · AP | Efficacy-New Patient Population | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214938s002lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214938Orig1s002ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/214938Orig1s002.pdf) | `48a50fef4222c478ff4de00f7852acafb36263855b47271d0e88992bdc22e927` | | 2024-11-04 | Supplement 4 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214938s004lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214938Orig1s004ltr.pdf) | `2994bb0eb92c8455101bbce2d052b682d1923d933a632f00a24b7d8bc0f93b7c` | ## NDA215256 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda215256/ - Profiles: Semaglutide - Submissions: 16; documents: 33 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2021-06-04 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215256Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215256Orig1s000TOC.html) | `f34f13fe334a2908488516d9c1cd89501426be2ecc001634eb223e0e337869e2` | | 2022-08-24 | Supplement 3 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s003lbl.pdf) | `89035603e1a889b4634f02274fdf2f14a26b6d8abd798a17bee84f720e62577c` | | 2022-12-23 | Supplement 5 · AP | Efficacy-New Patient Population | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s005lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215256Orig1s005ltr.pdf) | `e88a4f6e47f06af57c119fb6cd1d69aced80d73843122cb44410433cd9ba1f93` | | 2023-02-14 | Supplement 6 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256Orig1s006lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215256Orig1s006ltr.pdf) | `e9c5f12cfbc08c2245caed4153e5a5bb49dd78649809b28fad0872ce43412902` | | 2023-07-21 | Supplement 7 · AP | Efficacy-New Dosing Regimen | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215256Orig1s007ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf) | `f7828e6af42e301cb2c633a056bf4078a08ad33e743a79b25769f940eba769cb` | | 2024-03-08 | Supplement 11 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s011lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215256Orig1s011ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215256Orig1s011.pdf) | `91f763f80062fde6aa9741a94c07232c8dd459a39f8dc818e1446e71d2ef2e5d` | | 2024-11-01 | Supplement 21 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215256Orig1s021ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s021lbl.pdf) | `55395b83ef636bc63e28fc46345c5bf3cef73187333e20b571867c29a74fec70` | | 2024-11-27 | Supplement 15 · AP | Efficacy-New Dosing Regimen | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215256Orig1s015ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s015lbl.pdf) | `96b6c563799c389de5ddb9cb83343a4f626ffc33f204398abf87e6cb315cbdb9` | | 2025-08-15 | Supplement 24 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s024lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215256Orig1s024ltr.pdf) | `52d3571a5c4b16888cbf8fcbe2d7e766132d78a0d949d2c7a98a6200f4aad114` | | 2025-10-14 | Supplement 26 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215256Orig1s026ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s026lbl.pdf) | `d2dbdcdc861efc144ed848c26e1f383bdd4a992c5ad0501ef5854eac511b3764` | | 2025-11-21 | Supplement 23 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215256Orig1s023ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s023lbl.pdf) | `8752a6f1dcaf3d797f2a24390c5a73dc20e6c8b26143e75d23616db20e2dae8f` | | 2026-01-29 | Supplement 30 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s030;218316Orig1s002ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s030lbl.pdf) | `25b2203738dbb5202174209fa32f888a37d1c754506ecf98cc6385a0e5c1c92a` | | 2026-02-25 | Supplement 33 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s033,218316Orig1s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s033lbl.pdf) | `e65b082bae2ace3a10b6e02abe76e20cad0aa6b8ab731fc881285e025ebabc8f` | | 2026-03-19 | Supplement 29 · AP | Efficacy-New Dosing Regimen | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s029;218316Orig1s005ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf#page=51) | `da2f8bb18607a9e8ad147fc3e9341a8cae1e0646b41c23ced06a6708da1adaa7` | | 2026-05-05 | Supplement 31 · AP | Manufacturing (CMC)-Packaging | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s031lbl218316s003lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/215256Orig1s031.pdf) | `8ae2885695133e87d78b7f0b8df813bd4e4d3e13d29537adb9e128349017e1cb` | | 2026-06-18 | Supplement 25 · AP | Manufacturing (CMC)-Manufacturing Process | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf) | `f82784dfa8028bf7a3b72cf23ad27a99870f2535a4851063dc5e77e51949b2ce` | ## NDA215395 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda215395/ - Profiles: Lanreotide - Submissions: 3; documents: 7 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2021-12-17 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215395s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215395Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215395Orig1s000TOC.html) | `f0083f45a846cafc334af6258569fd2468bd425eda3b0cb38e19e0b4af5fc600` | | 2024-07-11 | Supplement 8 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215395Orig1s008ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215395s008lbl.pdf) | `47e985be58ef86080a253a22ef4720c2565cd235f5d383887420cd12c737ad8d` | | 2024-09-16 | Supplement 7 · AP | Efficacy-New Indication | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215395Orig1s007ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215395s007lbl.pdf) | `3d2b89ae9d09ec07a9f43ab15c31d6bb49403b9f4a9e0891bc7993978a4d9676` | ## NDA215866 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda215866/ - Profiles: Tirzepatide - Submissions: 11; documents: 27 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2022-05-13 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215866Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215866Orig1s000TOC.html) | `a46468f3c8d7a86a503ec342bc6e44929d48d6aa66d331868770b61f7c2c67fa` | | 2023-07-28 | Supplement 2 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215866Orig1s002,s006ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215866Orig1s002s006lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215866Orig1s002.pdf) | `20a17f116db0aab7e72fe4815284f510e1f6c55c906b6d3d87bf74205ba6efc9` | | 2023-07-28 | Supplement 6 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215866Orig1s002,s006ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215866Orig1s002s006lbl.pdf) | `bdb703e9d7f66a4a120a96df6095355a13ce337e903e75e07ba3e31d7c7c1030` | | 2024-11-01 | Supplement 10 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215866Orig1s010,%20s015,%20s022ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf) | `590488b73d1747fb32fe38158408b0f66672f357365cf4196a3466147cabac65` | | 2024-11-01 | Supplement 15 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215866Orig1s010,%20s015,%20s022ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf) | `b4f71260d3b9258769a52c279c09c5504fb38abefba94f67fd88cfad543d6184` | | 2024-11-01 | Supplement 22 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215866Orig1s010,%20s015,%20s022ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf) | `8d89e2bee6060d48df140b22ec13f740d1361205fc3142c32fbe8da6b493a585` | | 2025-05-28 | Supplement 31 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215866Orig1s031ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215866s031lbl.pdf) | `f322eedf7aab51ea6f14f06243dc12dedf41f76d953107cd79a7213f8bdfb209` | | 2025-09-25 | Supplement 34 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215866Orig1s034ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215866s034lbl.pdf) | `aef4459a657db5c812f28dfc6369413a6d831480d8567656e9d5fdbbfbb0e6f4` | | 2025-12-19 | Supplement 39 · AP | Efficacy-New Patient Population | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215866s039lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215866Orig1s039ltr.pdf) | `eb1e0eaaf8bfdef86ba96ed6fa7321cd48630467287761d21a7d3ec7482af307` | | 2026-01-07 | Supplement 41 · AP | Manufacturing (CMC)-Packaging | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215866Orig1s041ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s041lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s041lbl.pdf#page=24) | `4b3deb607491e8f13f9af777f9045242068d4075b9a5da6597b180838bfab160` | | 2026-01-20 | Supplement 9 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215866Orig1s009ltr.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215866Orig1s009ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf#page=25) | `56c7cd20a66a21e2df01d010c1370e8471c2b3f0266ab0117753942f0639c71b` | ## NDA217806 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda217806/ - Profiles: Tirzepatide - Submissions: 13; documents: 33 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2023-11-08 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217806Orig1s000ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217806Orig1s000TOC.html) | `b5d2ec9188be4c795ad21764b22ac7970e3124343cc7feb1cba13c49af55bbad` | | 2024-03-28 | Supplement 3 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s003lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s003Corrected_ltr.pdf) | `0052e4522d12821e481bda3f3b036b3c03983090cf0d51c2f77bc9ec6ebcb7c3` | | 2024-10-18 | Supplement 5 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005,%20006,%20011,%20015,%20019ltr.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005,%20006,%20011,%20015,%20019ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf) | `3334fba40712e52e4a5697804b2cfd62a4cfe2fb575fce642d42cb0659fd15e2` | | 2024-10-18 | Supplement 6 · AP | Efficacy-Labeling Change With Clinical Data | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005,%20006,%20011,%20015,%20019ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf) | `afe972b29b3099854356c12b0a67b8371557a85779fc6e2ab3f057664ca7a18f` | | 2024-10-18 | Supplement 11 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005,%20006,%20011,%20015,%20019ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf) | `b6ad6c9268ede63518b212d9e05995c651561a3052037a1108d599efdb54e0a7` | | 2024-10-18 | Supplement 15 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005,%20006,%20011,%20015,%20019ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf) | `62d2ee1c4efb401df59473d6a9ec89e5bca1d164733bae8dba6be717591bcc5c` | | 2024-10-18 | Supplement 19 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s005,%20006,%20011,%20015,%20019ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf) | `415cd03d2c7639a64d7a5625f000729d60fdfed49ed9e09134abfe708665c9c9` | | 2024-12-20 | Supplement 13 · AP | Efficacy-New Indication | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s013lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s013lbl.pdf#page=32), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s013ltr.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/217806Orig1s013.pdf) | `49ca19d371fba3000aeb30d78791a4f1600695bdb330c72a9e9fb940af9a0399` | | 2025-02-07 | Supplement 20 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217806Orig1s020ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217806Orig1s020lbl.pdf) | `91d71d68b44b8f7a84461bf99631ce70b6315f57653cd61e4f934deac7a576f9` | | 2025-09-25 | Supplement 31 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217806Orig1s031ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217806s031lbl.pdf) | `724d716d4781ff70e170a201643c328159ae5e7f88902cf60d973c5b65c905fa` | | 2026-01-07 | Supplement 37 · AP | Manufacturing (CMC)-Formulation | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s037ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf#page=32) | `f72628dc731168ab34b135b507c8e5fe2cecad12a649a1ce7e67ec39f6db5bb7` | | 2026-01-20 | Supplement 2 · AP | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s002ltr.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s002ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s002lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s002lbl.pdf#page=34) | `3f59dbb3e40c0b5bb520a174b7e264fc90ed3ab1ff3353967c3c62367d32d8ea` | | 2026-02-25 | Supplement 42 · AP | Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s042ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf) | `8fcdf394b0ca461f4c8fe7b3eec71bba9b041f077d159efd05eaa71aca031dc9` | ## NDA218316 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda218316/ - Profiles: Semaglutide - Submissions: 6; documents: 11 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2025-12-22 | Original submission 1 · AP | None listed | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218316Orig1s000ltr.pdf) | `f43fe7edb2362ccb932120c5ab08d5cb5e3601e0a63e4c5062cd745c1939099d` | | 2026-01-29 | Supplement 2 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s030;218316Orig1s002ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s002lbl.pdf) | `303157d42345b5f706c15d137147cb622fc2adb323e4932ee018ded874b033d1` | | 2026-02-25 | Supplement 4 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s033,218316Orig1s004ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s004lbl.pdf) | `1dbc03e1cef0325c91a649af2b81ca0b4f58de7868086ff7059547d211441ca0` | | 2026-03-19 | Supplement 5 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s029;218316Orig1s005ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s005lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s005lbl.pdf#page=51) | `d15b65c194788500a9bc81c7960f26687cdf08042d408dcd909a5bf4fec0ef06` | | 2026-05-05 | Supplement 3 · AP | Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s031lbl218316s003lbl.pdf) | `9a24e60a7d05a560a65fea9da16f0ae2cbb57f7a4a9c10393833305ac488cae1` | | 2026-06-18 | Supplement 7 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s007lbl.pdf) | `e7eda934a34966c91813ac5e1254bf1616a3a9e7c353158426e694d962b699bc` | ## NDA218771 - Human timeline: https://peptidescanner.com/regulatory/fda/applications/nda218771/ - Profiles: Teriparatide - Submissions: 3; documents: 8 | Status date | Submission | FDA action labels | Official documents | Record SHA-256 | | --- | --- | --- | --- | --- | | 2024-06-04 | Original submission 1 · AP | None listed | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218771Orig1s000ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218771s000lbl.pdf), [Review](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218771Orig1s000TOC.html) | `960609e12493c0660a8fced51dbfc5cc21378db5503a05d365b19b61d5921d3e` | | 2025-01-23 | Supplement 1 · AP | Labeling-Container/Carton Labels, Labeling-Package Insert | [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218771Orig1s001lbl.pdf), [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218771Orig1s001ltr.pdf) | `64ac37341aebb26cd1adb9a20afa37ea180139be45de4c618e932c5656cc5c84` | | 2026-08-03 | Supplement 2 · AP | Labeling-Medication Guide, Labeling-Package Insert | [Letter](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218771Orig1s002ltr.pdf), [Label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218771s002lbl.pdf), [Medication Guide](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218771s002lbl.pdf#page=20) | `5d9faa36477c2ba87d1403a073b4c275e2379f2f738da104115eef779739b619` |