Regulatory · source year
29 selected, source-linked regulatory records dated 2021. This is selective source coverage, not a complete timeline.
29 selected records.
15 connected profiles.
29 distinct public records.
Cited chronology
Abaloparatide
DailyMed lists Structured Product Labeling version 10 for the reviewed Abaloparatide label family with a published date of 2021-12-30. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lanreotide
The official Drugs@FDA dataset lists original submission 1 for NDA 215395 with status AP dated 2021-12-17, and names lanreotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Dulaglutide
DailyMed lists Structured Product Labeling version 41 for the reviewed Dulaglutide label family with a published date of 2021-12-09. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Tesamorelin
DailyMed lists Structured Product Labeling version 3 for the reviewed Tesamorelin label family with a published date of 2021-12-03. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Vosoritide
DailyMed lists Structured Product Labeling version 8 for the reviewed Vosoritide label family with a published date of 2021-12-03. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Vosoritide
The official Drugs@FDA dataset lists original submission 1 for NDA 214938 with status AP dated 2021-11-19, and names vosoritide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Glucagon + 1 more
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.
Source: Federal Register via GovInfo ↗
Afamelanotide
The Federal Register published notice 2021-24074, attributed to FDA and its parent HHS department, on 2021-11-04. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; SCENESSE,” and PeptideScanner's exact reviewed identity mapping connects the document to Afamelanotide.
Source: Federal Register via GovInfo ↗
Dulaglutide
DailyMed lists Structured Product Labeling version 40 for the reviewed Dulaglutide label family with a published date of 2021-10-18. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 39 for the reviewed Dulaglutide label family with a published date of 2021-10-12. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Afamelanotide
DailyMed lists Structured Product Labeling version 4 for the reviewed Afamelanotide label family with a published date of 2021-10-04. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Abaloparatide
DailyMed lists Structured Product Labeling version 9 for the reviewed Abaloparatide label family with a published date of 2021-09-29. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
DailyMed lists Structured Product Labeling version 28 for the reviewed Linaclotide label family with a published date of 2021-09-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Exenatide
The Federal Register published notice 2021-18928, attributed to FDA and its parent HHS department, on 2021-09-02. Its official title is “Proposal To Refuse To Approve a New Drug Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a Hearing,” and PeptideScanner's exact reviewed identity mapping connects the document to Exenatide.
Source: Federal Register via GovInfo ↗
Leuprolide + 1 more
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.
Source: Federal Register via GovInfo ↗
Leuprolide
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.
Source: Drugs@FDA via openFDA ↗
Lixisenatide
DailyMed lists Structured Product Labeling version 16 for the reviewed Lixisenatide label family with a published date of 2021-08-09. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Semaglutide
DailyMed lists Structured Product Labeling version 1 for the reviewed Semaglutide label family with a published date of 2021-06-07. 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 215256 with status AP dated 2021-06-04, and names semaglutide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Octreotide
The Federal Register published notice 2021-11575, attributed to FDA and its parent HHS department, on 2021-06-02. Its official title is “Determination That SANDOSTATIN (Octreotide Acetate) Injection, Equal to 0.2 Milligrams Base/Milliliter and Equal to 1 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” and PeptideScanner's exact reviewed identity mapping connects the document to Octreotide.
Source: Federal Register via GovInfo ↗
Abaloparatide
DailyMed lists Structured Product Labeling version 8 for the reviewed Abaloparatide label family with a published date of 2021-05-17. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Plecanatide
DailyMed lists Structured Product Labeling version 11 for the reviewed Plecanatide label family with a published date of 2021-04-27. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
DailyMed lists Structured Product Labeling version 27 for the reviewed Linaclotide label family with a published date of 2021-04-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 38 for the reviewed Dulaglutide label family with a published date of 2021-04-16. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
DailyMed lists Structured Product Labeling version 26 for the reviewed Linaclotide label family with a published date of 2021-04-16. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Bremelanotide + 1 more
The Federal Register published notice 2021-06202, attributed to FDA and its parent HHS department, on 2021-03-25. 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 Bremelanotide and Octreotide.
Source: Federal Register via GovInfo ↗
Plecanatide
DailyMed lists Structured Product Labeling version 9 for the reviewed Plecanatide label family with a published date of 2021-02-23. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
The official Drugs@FDA dataset lists original submission 1 for ANDA 209564 with status AP dated 2021-02-09, and names linaclotide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Dulaglutide
DailyMed lists Structured Product Labeling version 37 for the reviewed Dulaglutide label family with a published date of 2021-01-25. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.