ANDA 209611, held by Aurobindo Pharma. Linaclotide.
As of Nov 14, 2026, ANDA 209611 (Linaclotide), held by Aurobindo Pharma, was first approved by FDA on Feb 7, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2023 | Original application | Approved | None posted |
| Linaclotide145MCG · capsule;oral | Linaclotide | Discontinued |
| Linaclotide290MCG · capsule;oral | Linaclotide | Discontinued |
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
