Regulatory · source year
4 selected, source-linked regulatory records dated 2009. This is selective source coverage, not a complete timeline.
4 selected records.
3 connected profiles.
4 distinct public records.
Cited chronology
Exenatide
The official Drugs@FDA dataset lists original submission 1 for NDA 021919 with status AP dated 2009-10-30, and names exenatide synthetic among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Leuprolide
The Federal Register published notice E9-13272, attributed to FDA and its parent HHS department, on 2009-06-08. 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.
Source: Federal Register via GovInfo ↗
Liraglutide
The Federal Register published notice E9-5024, attributed to FDA and its parent HHS department, on 2009-03-10. 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.
Source: Federal Register via GovInfo ↗
Leuprolide
The official Drugs@FDA dataset lists original submission 1 for ANDA 078885 with status AP dated 2009-03-09, and names leuprolide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗