ANDA 71412, held by Hikma. Indomethacin.
As of Nov 15, 2026, ANDA 71412 (Indomethacin), held by Hikma, was first approved by FDA on Mar 18, 1987, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indomethacin25MG/5ML ยท suspension;oral | Indomethacin | 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
