Regulatory · source year
6 selected, source-linked regulatory records dated 2012. This is selective source coverage, not a complete timeline.
6 selected records.
6 connected profiles.
6 distinct public records.
Cited chronology
Linaclotide
DailyMed lists Structured Product Labeling version 2 for the reviewed Linaclotide label family with a published date of 2012-09-11. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
The official Drugs@FDA dataset lists original submission 1 for NDA 202811 with status AP dated 2012-08-30, and names linaclotide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Tesamorelin
The Federal Register published notice 2012-10808, attributed to FDA and its parent HHS department, on 2012-05-04. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; EGRIFTA,” and PeptideScanner's exact reviewed identity mapping connects the document to Tesamorelin.
Source: Federal Register via GovInfo ↗
Liraglutide
The Federal Register published notice 2012-10517, attributed to FDA and its parent HHS department, on 2012-05-02. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza,” 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 NDA 022200 with status AP dated 2012-01-27, and names exenatide synthetic among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Leuprolide + 1 more
The Federal Register published notice 2012-1433, attributed to FDA and its parent HHS department, on 2012-01-25. Its official title is “Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide and Octreotide.
Source: Federal Register via GovInfo ↗