Primary-source record
Decision-gradeFDA approval
ACTAVIS LABS FL · LINACLOTIDE approved (ANDA211255)
Drugs@FDA records an original approval for ANDA211255 on 20260924.
Key facts
- Filed
- Sep 24, 2026, 12:00 AM
- Event
- FDA approval
- Direction
- Positive
- Company
IRWDIronwood Pharma- Asset
- linaclotide
- Source
- openFDA
- Confidence
- Sourced
May 7, 2026
11:10 AM
IRWDIronwood Pharma