DailyMed lists Structured Product Labeling version 12 for the reviewed Abaloparatide label family with a published date of 2022-12-28. 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 Tesamorelin label family with a published date of 2022-12-26. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 47 for the reviewed Dulaglutide label family with a published date of 2022-12-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 30 for the reviewed Linaclotide label family with a published date of 2022-12-06. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 46 for the reviewed Dulaglutide label family with a published date of 2022-11-30. 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 Semaglutide label family with a published date of 2022-11-11. 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 Abaloparatide label family with a published date of 2022-11-10. 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 Leuprolide label family with a published date of 2022-11-07. 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 215336 with status AP dated 2022-10-28, and names leuprolide acetate among the application record's active ingredients.
DailyMed lists Structured Product Labeling version 3 for the reviewed Ziconotide label family with a published date of 2022-10-27. 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 Pramlintide label family with a published date of 2022-10-21. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The Federal Register published notice 2022-19155, attributed to FDA and its parent HHS department, on 2022-09-06. Its official title is “Issuance of Priority Review Voucher; Rare Pediatric Disease Product,” and PeptideScanner's exact reviewed identity mapping connects the document to Vosoritide.
The Federal Register published notice 2022-18523, attributed to FDA and its parent HHS department, on 2022-08-29. Its official title is “Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher,” and PeptideScanner's exact reviewed identity mapping connects the document to Tirzepatide.
The Federal Register published notice 2022-16502, attributed to FDA and its parent HHS department, on 2022-08-03. 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 Setmelanotide.
DailyMed lists Structured Product Labeling version 5 for the reviewed Setmelanotide label family with a published date of 2022-07-04. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The Federal Register published notice 2022-14134, attributed to FDA and its parent HHS department, on 2022-07-01. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; IMCIVREE,” and PeptideScanner's exact reviewed identity mapping connects the document to Setmelanotide.
DailyMed lists Structured Product Labeling version 45 for the reviewed Dulaglutide label family with a published date of 2022-06-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
DailyMed lists Structured Product Labeling version 17 for the reviewed Lixisenatide label family with a published date of 2022-06-20. 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 ANDA 212963 with status AP dated 2022-06-06, and names leuprolide acetate among the application record's active ingredients.
The Federal Register published notice 2022-10701, attributed to FDA and its parent HHS department, on 2022-05-20. 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 Exenatide and Linaclotide.
The official Drugs@FDA dataset lists original submission 1 for NDA 215866 with status AP dated 2022-05-13, and names tirzepatide among the application record's active ingredients.
DailyMed lists Structured Product Labeling version 4 for the reviewed Setmelanotide label family with a published date of 2022-04-27. 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 Setmelanotide label family with a published date of 2022-04-12. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
The Federal Register published notice 2022-03248, attributed to FDA and its parent HHS department, on 2022-02-18. 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.
DailyMed lists Structured Product Labeling version 42 for the reviewed Dulaglutide label family with a published date of 2022-02-15. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.