ANDA 211255, held by Actavis Labs Fl. Linaclotide.
As of Nov 14, 2026, ANDA 211255 (Linaclotide), held by Actavis Labs Fl, was first approved by FDA on Sep 24, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linaclotide72MCG ยท capsule;oral | Linaclotide | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
