DailyMed lists Structured Product Labeling version 17 for the reviewed Dulaglutide label family with a published date of 2016-12-21. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The Federal Register published notice 2016-30399, attributed to FDA and its parent HHS department, on 2016-12-19. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; TRULICITY,” and PeptideScanner's exact reviewed identity mapping connects the document to Dulaglutide.
DailyMed lists Structured Product Labeling version 16 for the reviewed Dulaglutide label family with a published date of 2016-11-25. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 1 for the reviewed Lixisenatide label family with a published date of 2016-11-22. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 12 for the reviewed Linaclotide label family with a published date of 2016-11-03. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 11 for the reviewed Linaclotide label family with a published date of 2016-09-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The official Drugs@FDA dataset lists original submission 1 for BLA 208471 with status AP dated 2016-07-27, and names lixisenatide among the application record's active ingredients.
DailyMed lists Structured Product Labeling version 4 for the reviewed Pramlintide label family with a published date of 2016-04-25. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 10 for the reviewed Linaclotide label family with a published date of 2016-04-18. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The Federal Register published notice 2016-05959, attributed to FDA and its parent HHS department, on 2016-03-17. Its official title is “Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting,” and PeptideScanner's exact reviewed identity mapping connects the document to Liraglutide.
The Federal Register published notice 2016-05931, attributed to FDA and its parent HHS department, on 2016-03-16. Its official title is “Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting,” and PeptideScanner's exact reviewed identity mapping connects the document to Lixisenatide.