Regulatory · source year
25 selected, source-linked regulatory records dated 2020. This is selective source coverage, not a complete timeline.
25 selected records.
14 connected profiles.
25 distinct public records.
Cited chronology
Glucagon
The official Drugs@FDA dataset lists original submission 1 for ANDA 208086 with status AP dated 2020-12-28, and names glucagon among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Setmelanotide
The Federal Register published notice 2020-27760, attributed to FDA and its parent HHS department, on 2020-12-17. Its official title is “Issuance of Priority Review Voucher; Rare Pediatric Disease Product,” and PeptideScanner's exact reviewed identity mapping connects the document to Setmelanotide.
Source: Federal Register via GovInfo ↗
Setmelanotide
DailyMed lists Structured Product Labeling version 1 for the reviewed Setmelanotide label family with a published date of 2020-12-16. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lixisenatide
DailyMed lists Structured Product Labeling version 15 for the reviewed Lixisenatide label family with a published date of 2020-12-04. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Setmelanotide
The official Drugs@FDA dataset lists original submission 1 for NDA 213793 with status AP dated 2020-11-25, and names setmelanotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Plecanatide
DailyMed lists Structured Product Labeling version 8 for the reviewed Plecanatide label family with a published date of 2020-11-12. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Abaloparatide
DailyMed lists Structured Product Labeling version 7 for the reviewed Abaloparatide label family with a published date of 2020-11-06. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
DailyMed lists Structured Product Labeling version 23 for the reviewed Linaclotide label family with a published date of 2020-10-01. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 36 for the reviewed Dulaglutide label family with a published date of 2020-09-15. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Bremelanotide
The Federal Register published notice 2020-18240, attributed to FDA and its parent HHS department, on 2020-08-20. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; VYLEESI,” and PeptideScanner's exact reviewed identity mapping connects the document to Bremelanotide.
Source: Federal Register via GovInfo ↗
Lixisenatide
DailyMed lists Structured Product Labeling version 14 for the reviewed Lixisenatide label family with a published date of 2020-07-16. 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 NDA 208232 with status AP dated 2020-06-26, and names octreotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Plecanatide
DailyMed lists Structured Product Labeling version 7 for the reviewed Plecanatide label family with a published date of 2020-05-04. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Leuprolide
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.
Source: Drugs@FDA via openFDA ↗
Tesamorelin
DailyMed lists Structured Product Labeling version 2 for the reviewed Tesamorelin label family with a published date of 2020-04-22. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Plecanatide
DailyMed lists Structured Product Labeling version 6 for the reviewed Plecanatide label family with a published date of 2020-04-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Afamelanotide
DailyMed lists Structured Product Labeling version 3 for the reviewed Afamelanotide label family with a published date of 2020-04-15. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lixisenatide
DailyMed lists Structured Product Labeling version 13 for the reviewed Lixisenatide label family with a published date of 2020-03-31. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Afamelanotide
DailyMed lists Structured Product Labeling version 2 for the reviewed Afamelanotide label family with a published date of 2020-03-27. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 35 for the reviewed Dulaglutide label family with a published date of 2020-03-06. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Liraglutide + 1 more
The Federal Register published notice 2020-04320, attributed to FDA and its parent HHS department, on 2020-03-03. 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 Liraglutide and Semaglutide.
Source: Federal Register via GovInfo ↗
Plecanatide
DailyMed lists Structured Product Labeling version 5 for the reviewed Plecanatide label family with a published date of 2020-02-18. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lixisenatide
DailyMed lists Structured Product Labeling version 12 for the reviewed Lixisenatide label family with a published date of 2020-01-24. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Semaglutide
The official Drugs@FDA dataset lists original submission 1 for NDA 213182 with status AP dated 2020-01-16, and names semaglutide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Dulaglutide
DailyMed lists Structured Product Labeling version 34 for the reviewed Dulaglutide label family with a published date of 2020-01-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.