Regulatory · source year
12 selected, source-linked regulatory records dated 2014. This is selective source coverage, not a complete timeline.
12 selected records.
6 connected profiles.
12 distinct public records.
Cited chronology
Liraglutide
The official Drugs@FDA dataset lists original submission 1 for NDA 206321 with status AP dated 2014-12-23, and names liraglutide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Dulaglutide
DailyMed lists Structured Product Labeling version 5 for the reviewed Dulaglutide label family with a published date of 2014-10-22. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Leuprolide
The Federal Register published notice 2014-23961, attributed to FDA and its parent HHS department, on 2014-10-08. Its official title is “Determination That LUPRON DEPOT (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
Source: Federal Register via GovInfo ↗
Dulaglutide
DailyMed lists Structured Product Labeling version 4 for the reviewed Dulaglutide label family with a published date of 2014-10-02. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Dulaglutide
The official Drugs@FDA dataset lists original submission 1 for BLA 125469 with status AP dated 2014-09-18, and names dulaglutide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Leuprolide
The Federal Register published notice 2014-19713, attributed to FDA and its parent HHS department, on 2014-08-20. Its official title is “Determination That LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial; and LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 7.5 Milligrams/Vial and 7.5 Milligrams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
Source: Federal Register via GovInfo ↗
Liraglutide
The Federal Register published notice 2014-18304, attributed to FDA and its parent HHS department, on 2014-08-04. 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 ↗
Lanreotide
The Federal Register published notice 2014-17293, attributed to FDA and its parent HHS department, on 2014-07-23. 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 Lanreotide.
Source: Federal Register via GovInfo ↗
Linaclotide
DailyMed lists Structured Product Labeling version 7 for the reviewed Linaclotide label family with a published date of 2014-07-17. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
DailyMed lists Structured Product Labeling version 6 for the reviewed Linaclotide label family with a published date of 2014-07-16. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Linaclotide
The Federal Register published notice 2014-11926, attributed to FDA and its parent HHS department, on 2014-05-23. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; LINZESS,” and PeptideScanner's exact reviewed identity mapping connects the document to Linaclotide.
Source: Federal Register via GovInfo ↗
Leuprolide + 1 more
The Federal Register published notice 2014-07330, attributed to FDA and its parent HHS department, on 2014-04-02. 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 ↗