Regulatory · source year
23 selected, source-linked regulatory records dated 2017. This is selective source coverage, not a complete timeline.
23 selected records.
12 connected profiles.
23 distinct public records.
Cited chronology
Semaglutide
The official Drugs@FDA dataset lists original submission 1 for NDA 209637 with status AP dated 2017-12-05, and names semaglutide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Octreotide
The Federal Register published notice 2017-25920, attributed to FDA and its parent HHS department, on 2017-12-01. Its official title is “Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications,” and PeptideScanner's exact reviewed identity mapping connects the document to Octreotide.
Source: Federal Register via GovInfo ↗
Linaclotide
DailyMed lists Structured Product Labeling version 17 for the reviewed Linaclotide label family with a published date of 2017-11-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 25 for the reviewed Dulaglutide label family with a published date of 2017-10-23. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Exenatide
The official Drugs@FDA dataset lists original submission 1 for NDA 209210 with status AP dated 2017-10-20, and names exenatide synthetic among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Lixisenatide
DailyMed lists Structured Product Labeling version 5 for the reviewed Lixisenatide label family with a published date of 2017-10-12. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Abaloparatide
DailyMed lists Structured Product Labeling version 2 for the reviewed Abaloparatide label family with a published date of 2017-10-10. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Semaglutide
The Federal Register published notice 2017-21176, attributed to FDA and its parent HHS department, on 2017-10-03. Its official title is “Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,” and PeptideScanner's exact reviewed identity mapping connects the document to Semaglutide.
Source: Federal Register via GovInfo ↗
Glucagon + 2 more
The Federal Register published notice 2017-21202, attributed to FDA and its parent HHS department, on 2017-10-03. Its official title is “Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Glucagon, Liraglutide and Teriparatide.
Source: Federal Register via GovInfo ↗
Lixisenatide
DailyMed lists Structured Product Labeling version 4 for the reviewed Lixisenatide label family with a published date of 2017-09-07. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 23 for the reviewed Dulaglutide label family with a published date of 2017-09-01. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 22 for the reviewed Dulaglutide label family with a published date of 2017-08-16. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
DailyMed lists Structured Product Labeling version 16 for the reviewed Linaclotide label family with a published date of 2017-07-03. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 21 for the reviewed Dulaglutide label family with a published date of 2017-06-28. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
DailyMed lists Structured Product Labeling version 15 for the reviewed Linaclotide label family with a published date of 2017-06-26. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Leuprolide + 1 more
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.
Source: Federal Register via GovInfo ↗
Linaclotide
DailyMed lists Structured Product Labeling version 14 for the reviewed Linaclotide label family with a published date of 2017-06-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Liraglutide
The Federal Register published notice 2017-10326, attributed to FDA and its parent HHS department, on 2017-05-22. Its official title is “Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments,” and PeptideScanner's exact reviewed identity mapping connects the document to Liraglutide.
Source: Federal Register via GovInfo ↗
Abaloparatide
DailyMed lists Structured Product Labeling version 1 for the reviewed Abaloparatide label family with a published date of 2017-05-04. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Abaloparatide
The official Drugs@FDA dataset lists original submission 1 for NDA 208743 with status AP dated 2017-04-28, and names abaloparatide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Linaclotide
DailyMed lists Structured Product Labeling version 13 for the reviewed Linaclotide label family with a published date of 2017-02-15. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 19 for the reviewed Dulaglutide label family with a published date of 2017-02-06. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Plecanatide
The official Drugs@FDA dataset lists original submission 1 for NDA 208745 with status AP dated 2017-01-19, and names plecanatide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗