ANDA 70900, held by Sun Pharm Industries. Indomethacin.
As of Nov 15, 2026, ANDA 70900 (Indomethacin), held by Sun Pharm Industries, was first approved by FDA on Feb 9, 1987, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 1987 | Original application | Approved | None posted |
| Indomethacin50MG · capsule;oral | Indomethacin | Discontinued |
| Indomethacin25MG · capsule;oral | Indomethacin | Discontinued |
| Nov 21, 2024 | Supplement 25Labeling · Standard review | Approved | None posted |
| Apr 30, 2021 | Supplement 24Labeling · Standard review | Approved | None posted |
| Apr 13, 2021 | Supplement 23Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 22Labeling · Standard review | Approved | None posted |
| Sep 27, 2006 | Supplement 21Labeling | Approved | None posted |
| Sep 10, 2002 | Supplement 12Labeling | Approved | None posted |
| May 16, 2000 | Supplement 11Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 10Manufacturing | Approved | None posted |
| Dec 5, 1997 | Supplement 9Manufacturing | Approved | None posted |
| Feb 24, 1997 | Supplement 8Manufacturing | Approved | None posted |
| Oct 17, 1996 | Supplement 7Labeling | Approved | None posted |
| Aug 13, 1996 | Supplement 6Manufacturing | Approved | None posted |
| Apr 29, 1996 | Supplement 5Labeling | Approved | None posted |
| Feb 2, 1994 | Supplement 3Manufacturing | Approved | None posted |
| Jan 12, 1994 | Supplement 4Manufacturing | Approved | None posted |
| Oct 12, 1989 | Supplement 2Labeling | Approved | None posted |
| Feb 24, 1988 | Supplement 1Labeling | Approved | None posted |
| Feb 9, 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
