Regulatory · source year
19 selected, source-linked regulatory records dated 2018. This is selective source coverage, not a complete timeline.
19 selected records.
9 connected profiles.
19 distinct public records.
Cited chronology
Linaclotide
The Federal Register published notice 2018-28213, attributed to FDA and its parent HHS department, on 2018-12-28. Its official title is “Product-Specific Guidance for Linaclotide; Draft Guidance for Industry; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Linaclotide.
Source: Federal Register via GovInfo ↗
Octreotide
The official Drugs@FDA dataset lists original submission 1 for ANDA 204669 with status AP dated 2018-12-27, and names octreotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Lixisenatide
The Federal Register published notice 2018-27805, attributed to FDA and its parent HHS department, on 2018-12-26. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; ADLYXIN,” and PeptideScanner's exact reviewed identity mapping connects the document to Lixisenatide.
Source: Federal Register via GovInfo ↗
Linaclotide
DailyMed lists Structured Product Labeling version 18 for the reviewed Linaclotide label family with a published date of 2018-12-07. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Plecanatide
The Federal Register published notice 2018-26289, attributed to FDA and its parent HHS department, on 2018-12-04. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; TRULANCE,” and PeptideScanner's exact reviewed identity mapping connects the document to Plecanatide.
Source: Federal Register via GovInfo ↗
Plecanatide
The Federal Register published notice 2018-25950, attributed to FDA and its parent HHS department, on 2018-11-29. 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 Plecanatide.
Source: Federal Register via GovInfo ↗
Pramlintide
DailyMed lists Structured Product Labeling version 11 for the reviewed Pramlintide label family with a published date of 2018-11-14. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 30 for the reviewed Dulaglutide label family with a published date of 2018-11-07. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Abaloparatide
DailyMed lists Structured Product Labeling version 5 for the reviewed Abaloparatide label family with a published date of 2018-11-01. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Ziconotide
DailyMed lists Structured Product Labeling version 1 for the reviewed Ziconotide label family with a published date of 2018-10-29. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Abaloparatide
The Federal Register published notice 2018-22956, attributed to FDA and its parent HHS department, on 2018-10-22. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOS,” and PeptideScanner's exact reviewed identity mapping connects the document to Abaloparatide.
Source: Federal Register via GovInfo ↗
Dulaglutide
DailyMed lists Structured Product Labeling version 29 for the reviewed Dulaglutide label family with a published date of 2018-10-11. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Octreotide
The official Drugs@FDA dataset lists original submission 1 for ANDA 203765 with status AP dated 2018-09-07, and names octreotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Leuprolide
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.
Source: Drugs@FDA via openFDA ↗
Abaloparatide
DailyMed lists Structured Product Labeling version 4 for the reviewed Abaloparatide label family with a published date of 2018-07-27. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 28 for the reviewed Dulaglutide label family with a published date of 2018-07-13. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lixisenatide
The Federal Register published notice 2018-07256, attributed to FDA and its parent HHS department, on 2018-04-10. Its official title is “Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers,” and PeptideScanner's exact reviewed identity mapping connects the document to Lixisenatide.
Source: Federal Register via GovInfo ↗
Lixisenatide
DailyMed lists Structured Product Labeling version 6 for the reviewed Lixisenatide label family with a published date of 2018-03-07. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Leuprolide
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.
Source: Federal Register via GovInfo ↗