ANDA 204243, held by Aurobindo Pharma. Indomethacin.
As of Nov 15, 2026, ANDA 204243 (Indomethacin), held by Aurobindo Pharma, was first approved by FDA on Dec 27, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indomethacin75MG ยท capsule, extended release;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
