Linaclotide · source year
5 selected, source-linked Linaclotide records carrying a 2021 source date. This is a navigational view of PeptideScanner’s selected coverage—not a complete research timeline or a statement about safety or effectiveness.
5 selected records.
2 represented types.
5 distinct public records.
Cited chronology
Regulatory
DailyMed lists Structured Product Labeling version 28 for the reviewed Linaclotide label family with a published date of 2021-09-08. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Safety
FDA's dated enforcement report D-0417-2021 lists Class II and source status Terminated for Cardinal Health Inc. PeptideScanner connects the report to reviewed application NDA202811 through exact openFDA application-number annotations.
Regulatory
DailyMed lists Structured Product Labeling version 27 for the reviewed Linaclotide label family with a published date of 2021-04-20. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Regulatory
DailyMed lists Structured Product Labeling version 26 for the reviewed Linaclotide label family with a published date of 2021-04-16. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Regulatory
The official Drugs@FDA dataset lists original submission 1 for ANDA 209564 with status AP dated 2021-02-09, and names linaclotide among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗