ANDA 71148, held by Ani Pharms. Indomethacin.
As of Nov 15, 2026, ANDA 71148 (Indomethacin), held by Ani Pharms, was first approved by FDA on Mar 18, 1987, with 16 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 · capsule;oral | Indomethacin | Discontinued |
| Nov 21, 2024 | Supplement 21Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 20Labeling · Standard review | Approved | None posted |
| Apr 17, 2021 | Supplement 19Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 18Labeling · Standard review | Approved | None posted |
| Aug 13, 2002 | Supplement 15Labeling | Approved | None posted |
| Jun 5, 2001 | Supplement 14Manufacturing | Approved | None posted |
| Jul 7, 2000 | Supplement 13Manufacturing | Approved | None posted |
| Jul 2, 1996 | Supplement 12Labeling | Approved | None posted |
| Apr 29, 1996 | Supplement 11Labeling | Approved | None posted |
| Jul 15, 1994 | Supplement 10Labeling | Approved | None posted |
| May 11, 1994 | Supplement 8Manufacturing | Approved | None posted |
| Nov 23, 1992 | Supplement 1Manufacturing | Approved | None posted |
| Nov 8, 1991 | Supplement 7Labeling | Approved | None posted |
| Apr 1, 1991 | Supplement 6Labeling | Approved | None posted |
| Feb 24, 1989 | Supplement 5Labeling | Approved | None posted |
| Feb 8, 1989 | Supplement 4Labeling | Approved | None posted |
| Mar 18, 1987 | Original application | Approved | None posted |
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
