Profile change history
A deterministic history of records added to PeptideScanner and preserved profile or record revisions connected through the reviewed Leuprolide identity.
Before and after
We rewrote the profile summary to describe the cited public record more directly. The cited sources and status did not change.
Collection chronology
Showing the latest 100 additions by PeptideScanner publication date; the complete connected record set remains available in Latest Research. Most recent addition: August 25, 2026.
FDA's dated enforcement report D-1178-2023 lists Class III and source status Terminated for Tolmar, Inc. PeptideScanner connects the report to reviewed application NDA021379 through exact openFDA application-number annotations.
FDA's dated enforcement report D-1287-2014 lists Class II and source status Terminated for AbbVie Inc. PeptideScanner connects the report to reviewed application NDA020517 through exact openFDA application-number annotations.
FDA's dated enforcement report D-1288-2014 lists Class II and source status Terminated for AbbVie Inc. PeptideScanner connects the report to reviewed application NDA020517 through exact openFDA application-number annotations.
FDA's dated enforcement report D-1289-2014 lists Class II and source status Terminated for AbbVie Inc. PeptideScanner connects the report to reviewed application NDA020263 through exact openFDA application-number annotations.
FDA's dated enforcement report D-1290-2014 lists Class II and source status Terminated for AbbVie Inc. PeptideScanner connects the report to reviewed application NDA020708 through exact openFDA application-number annotations.
FDA's dated enforcement report D-1291-2014 lists Class II and source status Terminated for AbbVie Inc. PeptideScanner connects the report to reviewed application NDA020517 through exact openFDA application-number annotations.
DailyMed lists Structured Product Labeling version 10 for the reviewed Leuprolide label family with a published date of 2026-07-06. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 4 for the reviewed Leuprolide label family with a published date of 2022-11-07. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 5 for the reviewed Leuprolide label family with a published date of 2023-03-07. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 6 for the reviewed Leuprolide label family with a published date of 2024-11-18. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 7 for the reviewed Leuprolide label family with a published date of 2025-04-28. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 9 for the reviewed Leuprolide label family with a published date of 2025-12-29. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The Federal Register published notice 05-20301, attributed to FDA and its parent HHS department, on 2005-10-07. Its official title is “Solicitation of Public Review and Comment on Research Protocol: Gonadotropin-releasing Hormone Agonist Test in Disorders of Puberty,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 05-20302, attributed to FDA and its parent HHS department, on 2005-10-07. Its official title is “Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 2011-14164, attributed to FDA and its parent HHS department, on 2011-06-08. Its official title is “Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 2012-1433, attributed to FDA and its parent HHS department, on 2012-01-25. Its official title is “Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide and Octreotide.
The Federal Register published notice 2014-07330, attributed to FDA and its parent HHS department, on 2014-04-02. Its official title is “Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide and Octreotide.
The Federal Register published notice 2014-19713, attributed to FDA and its parent HHS department, on 2014-08-20. Its official title is “Determination That LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial; and LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 7.5 Milligrams/Vial and 7.5 Milligrams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 2014-23961, attributed to FDA and its parent HHS department, on 2014-10-08. Its official title is “Determination That LUPRON DEPOT (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 2017-12908, attributed to FDA and its parent HHS department, on 2017-06-21. Its official title is “Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide and Octreotide.
The Federal Register published notice 2018-02667, attributed to FDA and its parent HHS department, on 2018-02-09. Its official title is “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 2019-11243, attributed to FDA and its parent HHS department, on 2019-05-30. Its official title is “Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 2021-18072, attributed to FDA and its parent HHS department, on 2021-08-23. Its official title is “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide and Semaglutide.
The Federal Register published notice 2021-24431, attributed to FDA and its parent HHS department, on 2021-11-09. Its official title is “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Glucagon and Leuprolide.
The Federal Register published notice 2022-03248, attributed to FDA and its parent HHS department, on 2022-02-18. Its official title is “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 2023-03364, attributed to FDA and its parent HHS department, on 2023-02-17. Its official title is “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Afamelanotide, Glucagon, Leuprolide and Vosoritide.
The Federal Register published notice 2024-04218, attributed to FDA and its parent HHS department, on 2024-02-29. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; CAMCEVI,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 2024-08657, attributed to FDA and its parent HHS department, on 2024-04-23. Its official title is “PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 98-13045, attributed to FDA and its parent HHS department, on 1998-05-18. Its official title is “Environmental Assessments and Findings of No Significant Impact,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice E9-13272, attributed to FDA and its parent HHS department, on 2009-06-08. Its official title is “Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
PubMed lists PMID 16312848 in Journal of chemotherapy (Florence, Italy) as Journal Article, with publication-date metadata of 1989-07 (month precision). PeptideScanner associated the retained record with the identity slug leuprolide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
PeptideScanner retained ClinicalTrials.gov record NCT05896293 at 2026-08-10T18:10:03.920Z. Its registry update date was 2026-07-13, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT07455903 at 2026-08-13T05:52:27.015Z. Its registry update date was 2026-08-06, and PeptideScanner's reviewed identity mapping was leuprolide.
The official Drugs@FDA dataset lists original submission 1 for ANDA 074728 with status AP dated 1998-08-04, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 075471 with status AP dated 2000-10-25, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 075721 with status AP dated 2001-11-29, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 078885 with status AP dated 2009-03-09, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 212963 with status AP dated 2022-06-06, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 213829 with status AP dated 2021-08-13, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 215336 with status AP dated 2022-10-28, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 215826 with status AP dated 2025-11-13, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 217437 with status AP dated 2025-06-09, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 217957 with status AP dated 2024-10-17, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 019010 with status AP dated 1985-04-09, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 019732 with status AP dated 1989-01-26, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 019943 with status AP dated 1995-03-30, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 020011 with status AP dated 1990-10-22, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 020263 with status AP dated 1993-04-16, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 020517 with status AP dated 1995-12-22, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 020708 with status AP dated 1997-03-07, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 021088 with status AP dated 2000-03-03, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 021343 with status AP dated 2002-01-23, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 021379 with status AP dated 2002-07-24, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 021488 with status AP dated 2003-02-13, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 021731 with status AP dated 2004-12-14, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 205054 with status AP dated 2018-08-28, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 213150 with status AP dated 2020-05-01, and names leuprolide acetate among the application record's active ingredients.
PubMed lists PMID 15685898 in The Netherlands journal of medicine as Case Reports, Journal Article, with publication-date metadata of 2004-12 (month precision). PeptideScanner associated the retained record with the identity slug leuprolide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
PubMed lists PMID 15689930 in The Journal of pediatrics as Comment, Letter, with publication-date metadata of 2005-02 (month precision). PeptideScanner associated the retained record with the identity slug leuprolide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
PubMed lists PMID 15862697 in Journal of pharmaceutical and biomedical analysis as Journal Article, Research Support, Non-U.S. Gov't, with publication-date metadata of 2005-04-29 (day precision). PeptideScanner associated the retained record with the identity slug leuprolide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
PubMed lists PMID 16111462 in Expert review of anticancer therapy as Journal Article, Review, with publication-date metadata of 2005-08 (month precision). PeptideScanner associated the retained record with the identity slug leuprolide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
PeptideScanner retained ClinicalTrials.gov record NCT00002580 at 2026-07-30T21:55:56.626Z. Its registry update date was 2013-11-06, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00002582 at 2026-07-30T21:55:56.631Z. Its registry update date was 2013-08-02, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00002881 at 2026-07-30T22:25:23.114Z. Its registry update date was 2010-11-09, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00003124 at 2026-07-30T21:54:46.538Z. Its registry update date was 2014-01-06, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00003394 at 2026-07-30T21:55:56.623Z. Its registry update date was 2013-06-24, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00004311 at 2026-07-30T22:50:58.187Z. Its registry update date was 2005-06-24, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00004344 at 2026-07-30T22:50:58.186Z. Its registry update date was 2005-06-24, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00004426 at 2026-07-30T21:43:54.469Z. Its registry update date was 2015-03-26, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00004436 at 2026-07-30T21:43:54.456Z. Its registry update date was 2015-03-25, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00004438 at 2026-07-30T21:43:54.452Z. Its registry update date was 2015-03-25, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00004771 at 2026-07-30T22:50:58.183Z. Its registry update date was 2005-06-24, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00063310 at 2026-07-30T22:26:45.017Z. Its registry update date was 2009-12-11, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00170157 at 2026-07-30T21:24:24.228Z. Its registry update date was 2017-05-15, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00225420 at 2026-07-30T21:24:24.228Z. Its registry update date was 2017-06-01, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00349258 at 2026-07-30T22:49:18.182Z. Its registry update date was 2006-07-06, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00380406 at 2026-07-30T21:24:24.229Z. Its registry update date was 2017-04-05, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00429494 at 2026-07-30T21:55:56.622Z. Its registry update date was 2013-07-09, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00454571 at 2026-07-30T21:38:42.855Z. Its registry update date was 2016-02-10, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00500110 at 2026-07-30T21:42:40.792Z. Its registry update date was 2015-04-28, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00589472 at 2026-07-30T21:22:00.251Z. Its registry update date was 2017-10-06, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00631527 at 2026-07-30T21:43:54.453Z. Its registry update date was 2015-01-29, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00653757 at 2026-07-30T22:14:20.913Z. Its registry update date was 2012-03-19, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00669162 at 2026-07-30T20:48:52.438Z. Its registry update date was 2019-07-24, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00805935 at 2026-07-30T22:14:20.915Z. Its registry update date was 2012-01-27, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00903162 at 2026-07-30T21:37:20.822Z. Its registry update date was 2016-04-18, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00928434 at 2026-07-30T21:34:56.510Z. Its registry update date was 2016-12-13, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT00943956 at 2026-07-30T21:37:20.823Z. Its registry update date was 2016-05-25, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01023061 at 2026-07-30T21:24:24.232Z. Its registry update date was 2017-06-06, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01076335 at 2026-07-30T21:36:16.908Z. Its registry update date was 2016-09-19, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01088529 at 2026-07-30T21:54:46.544Z. Its registry update date was 2014-05-15, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01116401 at 2026-07-30T21:12:47.405Z. Its registry update date was 2018-01-23, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01120236 at 2026-07-30T21:12:47.407Z. Its registry update date was 2018-02-26, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01160328 at 2026-07-30T21:54:46.559Z. Its registry update date was 2014-05-14, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01431391 at 2026-07-30T21:24:24.227Z. Its registry update date was 2017-05-30, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01669291 at 2026-07-30T21:54:46.557Z. Its registry update date was 2014-06-04, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01750398 at 2026-07-30T21:34:56.506Z. Its registry update date was 2016-12-05, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT01762943 at 2026-07-30T21:22:00.263Z. Its registry update date was 2017-11-20, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT02107391 at 2026-07-30T21:24:24.227Z. Its registry update date was 2017-05-24, and PeptideScanner's reviewed identity mapping was leuprolide.
PeptideScanner retained ClinicalTrials.gov record NCT02319837 at 2026-08-10T18:10:03.933Z. Its registry update date was 2026-07-09, and PeptideScanner's reviewed identity mapping was leuprolide.