Regulatory · source year
53 selected, source-linked regulatory records dated 2024. This is selective source coverage, not a complete timeline.
53 selected records.
21 connected profiles.
53 distinct public records.
Cited chronology
Teriparatide
DailyMed lists Structured Product Labeling version 6 for the reviewed Teriparatide label family with a published date of 2024-12-30. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Tirzepatide
DailyMed lists Structured Product Labeling version 14 for the reviewed Tirzepatide label family with a published date of 2024-12-30. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Tesamorelin
DailyMed lists Structured Product Labeling version 7 for the reviewed Tesamorelin label family with a published date of 2024-12-23. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Liraglutide
The official Drugs@FDA dataset lists original submission 1 for ANDA 215503 with status AP dated 2024-12-23, and names liraglutide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Vosoritide
DailyMed lists Structured Product Labeling version 15 for the reviewed Vosoritide label family with a published date of 2024-12-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Semaglutide
DailyMed lists Structured Product Labeling version 10 for the reviewed Semaglutide label family with a published date of 2024-12-12. 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 ANDA 204468 with status AP dated 2024-12-12, and names glucagon among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Lanreotide
DailyMed lists Structured Product Labeling version 2 for the reviewed Lanreotide label family with a published date of 2024-12-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Exenatide
DailyMed lists Structured Product Labeling version 11 for the reviewed Exenatide label family with a published date of 2024-11-25. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Liraglutide
The Federal Register published notice 2024-27048, attributed to FDA and its parent HHS department, on 2024-11-20. 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 Liraglutide.
Source: Federal Register via GovInfo ↗
Exenatide
The official Drugs@FDA dataset lists original submission 1 for ANDA 206697 with status AP dated 2024-11-19, and names exenatide synthetic among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Leuprolide
DailyMed lists Structured Product Labeling version 6 for the reviewed Leuprolide label family with a published date of 2024-11-18. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Semaglutide
DailyMed lists Structured Product Labeling version 9 for the reviewed Semaglutide label family with a published date of 2024-11-15. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
DailyMed lists Structured Product Labeling version 54 for the reviewed Dulaglutide label family with a published date of 2024-11-14. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lixisenatide
DailyMed lists Structured Product Labeling version 19 for the reviewed Lixisenatide label family with a published date of 2024-11-14. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Vosoritide
DailyMed lists Structured Product Labeling version 14 for the reviewed Vosoritide label family with a published date of 2024-11-13. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Tirzepatide
DailyMed lists Structured Product Labeling version 12 for the reviewed Tirzepatide label family with a published date of 2024-11-04. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
CJC-1295
The Federal Register published notice 2024-24828, attributed to FDA and its parent HHS department, on 2024-10-25. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,” and PeptideScanner's exact reviewed identity mapping connects the document to CJC-1295.
Source: Federal Register via GovInfo ↗
Leuprolide
The official Drugs@FDA dataset lists original submission 1 for ANDA 217957 with status AP dated 2024-10-17, and names leuprolide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Octreotide
The official Drugs@FDA dataset lists original submission 1 for NDA 213224 with status AP dated 2024-09-27, and names octreotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Ipamorelin
The Federal Register published notice 2024-21241, attributed to FDA and its parent HHS department, on 2024-09-18. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List,” and PeptideScanner's exact reviewed identity mapping connects the document to Ipamorelin.
Source: Federal Register via GovInfo ↗
Elamipretide
The Federal Register published notice 2024-20062, attributed to FDA and its parent HHS department, on 2024-09-06. Its official title is “Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 215244 for Elamipretide Hydrochloride Injection,” and PeptideScanner's exact reviewed identity mapping connects the document to Elamipretide.
Source: Federal Register via GovInfo ↗
Exenatide + 1 more
The Federal Register published notice 2024-18898, attributed to FDA and its parent HHS department, on 2024-08-23. Its official title is “Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650,” and PeptideScanner's exact reviewed identity mapping connects the document to Exenatide and Glucagon.
Source: Federal Register via GovInfo ↗
Teriparatide
The Federal Register published notice 2024-18997, attributed to FDA and its parent HHS department, on 2024-08-23. 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 Teriparatide.
Source: Federal Register via GovInfo ↗
Pramlintide
DailyMed lists Structured Product Labeling version 18 for the reviewed Pramlintide label family with a published date of 2024-08-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Afamelanotide
DailyMed lists Structured Product Labeling version 8 for the reviewed Afamelanotide label family with a published date of 2024-08-16. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Tirzepatide
DailyMed lists Structured Product Labeling version 8 for the reviewed Tirzepatide label family with a published date of 2024-08-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Glucagon
The Federal Register published notice 2024-17649, attributed to FDA and its parent HHS department, on 2024-08-08. Its official title is “Determination That DELATESTRYL (Testosterone Enanthate) Injection, 200 Milligrams/Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” and PeptideScanner's exact reviewed identity mapping connects the document to Glucagon.
Source: Federal Register via GovInfo ↗
Dulaglutide
DailyMed lists Structured Product Labeling version 51 for the reviewed Dulaglutide label family with a published date of 2024-07-26. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
DailyMed lists Structured Product Labeling version 34 for the reviewed Linaclotide label family with a published date of 2024-07-11. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Pramlintide
DailyMed lists Structured Product Labeling version 17 for the reviewed Pramlintide label family with a published date of 2024-07-09. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Teriparatide
DailyMed lists Structured Product Labeling version 5 for the reviewed Teriparatide label family with a published date of 2024-07-04. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Teriparatide
The official Drugs@FDA dataset lists original submission 1 for NDA 218771 with status AP dated 2024-06-04, and names teriparatide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Glucagon
The Federal Register published notice 2024-12065, attributed to FDA and its parent HHS department, on 2024-06-03. Its official title is “Pfizer, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications,” and PeptideScanner's exact reviewed identity mapping connects the document to Glucagon.
Source: Federal Register via GovInfo ↗
Lanreotide
DailyMed lists Structured Product Labeling version 1 for the reviewed Lanreotide label family with a published date of 2024-05-23. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Lanreotide
The official Drugs@FDA dataset lists original submission 1 for ANDA 217193 with status AP dated 2024-05-21, and names lanreotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Liraglutide
The Federal Register published notice 2024-10896, attributed to FDA and its parent HHS department, on 2024-05-17. 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 Liraglutide.
Source: Federal Register via GovInfo ↗
Octreotide
The official Drugs@FDA dataset lists original submission 1 for ANDA 217860 with status AP dated 2024-05-02, and names octreotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Leuprolide
The Federal Register published notice 2024-08657, attributed to FDA and its parent HHS department, on 2024-04-23. Its official title is “PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
Source: Federal Register via GovInfo ↗
Pramlintide
DailyMed lists Structured Product Labeling version 16 for the reviewed Pramlintide label family with a published date of 2024-04-15. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Vosoritide
DailyMed lists Structured Product Labeling version 12 for the reviewed Vosoritide label family with a published date of 2024-04-15. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Semaglutide
DailyMed lists Structured Product Labeling version 8 for the reviewed Semaglutide label family with a published date of 2024-04-12. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Tirzepatide
DailyMed lists Structured Product Labeling version 5 for the reviewed Tirzepatide label family with a published date of 2024-04-12. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Vosoritide
DailyMed lists Structured Product Labeling version 11 for the reviewed Vosoritide label family with a published date of 2024-04-12. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Plecanatide
DailyMed lists Structured Product Labeling version 15 for the reviewed Plecanatide label family with a published date of 2024-04-05. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Semaglutide
DailyMed lists Structured Product Labeling version 7 for the reviewed Semaglutide label family with a published date of 2024-03-18. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Tesamorelin
DailyMed lists Structured Product Labeling version 6 for the reviewed Tesamorelin label family with a published date of 2024-03-14. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Abaloparatide
DailyMed lists Structured Product Labeling version 16 for the reviewed Abaloparatide label family with a published date of 2024-03-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Vosoritide
The Federal Register published notice 2024-04479, attributed to FDA and its parent HHS department, on 2024-03-04. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; VOXZOGO,” and PeptideScanner's exact reviewed identity mapping connects the document to Vosoritide.
Source: Federal Register via GovInfo ↗
Tirzepatide
The Federal Register published notice 2024-04157, attributed to FDA and its parent HHS department, on 2024-02-29. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; MOUNJARO,” and PeptideScanner's exact reviewed identity mapping connects the document to Tirzepatide.
Source: Federal Register via GovInfo ↗
Leuprolide
The Federal Register published notice 2024-04218, attributed to FDA and its parent HHS department, on 2024-02-29. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; CAMCEVI,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
Source: Federal Register via GovInfo ↗
Tesamorelin
DailyMed lists Structured Product Labeling version 5 for the reviewed Tesamorelin label family with a published date of 2024-02-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Teriparatide
DailyMed lists Structured Product Labeling version 4 for the reviewed Teriparatide label family with a published date of 2024-01-31. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.