Regulatory · source year
24 selected, source-linked regulatory records dated 2019. This is selective source coverage, not a complete timeline.
24 selected records.
13 connected profiles.
24 distinct public records.
Cited chronology
Afamelanotide
DailyMed lists Structured Product Labeling version 1 for the reviewed Afamelanotide label family with a published date of 2019-12-31. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Pramlintide
DailyMed lists Structured Product Labeling version 12 for the reviewed Pramlintide label family with a published date of 2019-12-24. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lixisenatide
DailyMed lists Structured Product Labeling version 11 for the reviewed Lixisenatide label family with a published date of 2019-12-19. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lixisenatide
DailyMed lists Structured Product Labeling version 10 for the reviewed Lixisenatide label family with a published date of 2019-12-12. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lixisenatide
DailyMed lists Structured Product Labeling version 9 for the reviewed Lixisenatide label family with a published date of 2019-12-10. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Semaglutide
The Federal Register published notice 2019-25850, attributed to FDA and its parent HHS department, on 2019-11-29. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; OZEMPIC,” and PeptideScanner's exact reviewed identity mapping connects the document to Semaglutide.
Source: Federal Register via GovInfo ↗
Abaloparatide
DailyMed lists Structured Product Labeling version 6 for the reviewed Abaloparatide label family with a published date of 2019-11-26. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lixisenatide
DailyMed lists Structured Product Labeling version 8 for the reviewed Lixisenatide label family with a published date of 2019-11-26. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Plecanatide
DailyMed lists Structured Product Labeling version 4 for the reviewed Plecanatide label family with a published date of 2019-11-13. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Plecanatide
DailyMed lists Structured Product Labeling version 3 for the reviewed Plecanatide label family with a published date of 2019-11-07. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Tesamorelin
DailyMed lists Structured Product Labeling version 1 for the reviewed Tesamorelin label family with a published date of 2019-11-05. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Afamelanotide
The official Drugs@FDA dataset lists original submission 1 for NDA 210797 with status AP dated 2019-10-08, and names afamelanotide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Teriparatide
The official Drugs@FDA dataset lists original submission 1 for NDA 211939 with status AP dated 2019-10-04, and names teriparatide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Semaglutide
The official Drugs@FDA dataset lists original submission 1 for NDA 213051 with status AP dated 2019-09-20, and names semaglutide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Plecanatide
The Federal Register published notice 2019-20108, attributed to FDA and its parent HHS department, on 2019-09-17. 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 Plecanatide.
Source: Federal Register via GovInfo ↗
Glucagon
The official Drugs@FDA dataset lists original submission 1 for NDA 212097 with status AP dated 2019-09-10, and names glucagon among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Ziconotide
DailyMed lists Structured Product Labeling version 2 for the reviewed Ziconotide label family with a published date of 2019-08-23. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Plecanatide
DailyMed lists Structured Product Labeling version 2 for the reviewed Plecanatide label family with a published date of 2019-07-26. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Glucagon
The official Drugs@FDA dataset lists original submission 1 for NDA 210134 with status AP dated 2019-07-24, and names glucagon among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Bremelanotide
The official Drugs@FDA dataset lists original submission 1 for NDA 210557 with status AP dated 2019-06-21, and names bremelanotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Plecanatide
DailyMed lists Structured Product Labeling version 1 for the reviewed Plecanatide label family with a published date of 2019-06-19. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
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.
Source: Federal Register via GovInfo ↗
Lixisenatide
DailyMed lists Structured Product Labeling version 7 for the reviewed Lixisenatide label family with a published date of 2019-03-05. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 31 for the reviewed Dulaglutide label family with a published date of 2019-01-24. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.