DailyMed lists Structured Product Labeling version 3 for the reviewed Teriparatide label family with a published date of 2023-12-13. 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 ANDA 210317 with status AP dated 2023-12-05, and names octreotide acetate among the application record's active ingredients.
DailyMed lists Structured Product Labeling version 1 for the reviewed Octreotide label family with a published date of 2023-12-01. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 5 for the reviewed Ziconotide label family with a published date of 2023-12-01. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 15 for the reviewed Abaloparatide label family with a published date of 2023-11-30. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 6 for the reviewed Setmelanotide label family with a published date of 2023-11-29. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 2 for the reviewed Teriparatide label family with a published date of 2023-11-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The Federal Register published notice 2023-25485, attributed to FDA and its parent HHS department, on 2023-11-17. 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 Semaglutide.
DailyMed lists Structured Product Labeling version 3 for the reviewed Tirzepatide label family with a published date of 2023-11-16. 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 ANDA 208569 with status AP dated 2023-11-16, and names teriparatide among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 211097 with status AP dated 2023-11-16, and names teriparatide among the application record's active ingredients.
DailyMed lists Structured Product Labeling version 10 for the reviewed Vosoritide label family with a published date of 2023-11-15. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 2 for the reviewed Tirzepatide label family with a published date of 2023-11-14. 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 NDA 217806 with status AP dated 2023-11-08, and names tirzepatide among the application record's active ingredients.
DailyMed lists Structured Product Labeling version 49 for the reviewed Dulaglutide label family with a published date of 2023-10-18. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 7 for the reviewed Afamelanotide label family with a published date of 2023-10-17. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 18 for the reviewed Lixisenatide label family with a published date of 2023-10-12. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 33 for the reviewed Linaclotide label family with a published date of 2023-09-21. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The Federal Register published notice 2023-18241, attributed to FDA and its parent HHS department, on 2023-08-24. Its official title is “Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Alternative Form of Hearing,” and PeptideScanner's exact reviewed identity mapping connects the document to Exenatide.
The Federal Register published notice 2023-18250, attributed to FDA and its parent HHS department, on 2023-08-24. 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 Exenatide.
The Federal Register published notice 2023-18026, attributed to FDA and its parent HHS department, on 2023-08-22. 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 Tirzepatide.
DailyMed lists Structured Product Labeling version 6 for the reviewed Semaglutide label family with a published date of 2023-08-01. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 13 for the reviewed Abaloparatide label family with a published date of 2023-06-28. 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 ANDA 216839 with status AP dated 2023-06-22, and names octreotide acetate among the application record's active ingredients.
DailyMed lists Structured Product Labeling version 32 for the reviewed Linaclotide label family with a published date of 2023-06-21. 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 ANDA 216807 with status AP dated 2023-06-13, and names octreotide acetate among the application record's active ingredients.
DailyMed lists Structured Product Labeling version 6 for the reviewed Afamelanotide label family with a published date of 2023-05-17. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 31 for the reviewed Linaclotide label family with a published date of 2023-05-05. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 48 for the reviewed Dulaglutide label family with a published date of 2023-05-01. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 14 for the reviewed Plecanatide label family with a published date of 2023-04-06. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 4 for the reviewed Ziconotide label family with a published date of 2023-03-24. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 13 for the reviewed Plecanatide label family with a published date of 2023-03-14. 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 Plecanatide label family with a published date of 2023-03-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 5 for the reviewed Semaglutide label family with a published date of 2023-03-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 5 for the reviewed Leuprolide label family with a published date of 2023-03-07. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 4 for the reviewed Semaglutide label family with a published date of 2023-02-27. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 14 for the reviewed Pramlintide label family with a published date of 2023-02-23. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The Federal Register published notice 2023-03364, attributed to FDA and its parent HHS department, on 2023-02-17. 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 Afamelanotide, Glucagon, Leuprolide and Vosoritide.
The official Drugs@FDA dataset lists original submission 1 for ANDA 209611 with status AP dated 2023-02-07, and names linaclotide among the application record's active ingredients.
DailyMed lists Structured Product Labeling version 5 for the reviewed Afamelanotide label family with a published date of 2023-01-24. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 3 for the reviewed Semaglutide label family with a published date of 2023-01-09. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.