ANDA 216905, held by Annora Pharma. Indomethacin.
As of Nov 15, 2026, ANDA 216905 (Indomethacin), held by Annora Pharma, was first approved by FDA on Jul 3, 2025, with 0 approved supplements and 0 published complete response letters.
Indomethacin Suppository is indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 3, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indomethacin50MG · suppository;rectal | Indomethacin | 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
