NDA 18851, held by Heritage. Indomethacin.
As of Nov 15, 2026, NDA 18851 (Indomethacin), held by Heritage, was first approved by FDA on May 18, 1984, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 1984 | Original application | Approved | None posted |
| Indomethacin25MG · capsule;oral | Indomethacin | Discontinued |
| Indomethacin50MG · capsule;oral | Indomethacin | Discontinued |
| Nov 21, 2024 | Supplement 29Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 28Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 25Labeling · Standard review | Approved | |
| Aug 7, 1992 | Supplement 23Labeling | Approved | None posted |
| May 25, 1990 | Supplement 20Manufacturing | Approved | None posted |
| Oct 4, 1989 | Supplement 22Labeling | Approved | None posted |
| Oct 4, 1989 | Supplement 31Labeling | Approved | None posted |
| Mar 16, 1989 | Supplement 21Labeling | Approved | None posted |
| Mar 16, 1989 | Supplement 30Labeling | Approved | None posted |
| Feb 13, 1989 | Supplement 17Manufacturing | Approved | None posted |
| Feb 13, 1989 | Supplement 19Manufacturing | Approved | None posted |
| Feb 23, 1988 | Supplement 18Manufacturing | Approved | None posted |
| May 14, 1987 | Supplement 13Manufacturing | Approved | None posted |
| Aug 19, 1986 | Supplement 14Manufacturing | Approved | None posted |
| Oct 24, 1985 | Supplement 8Manufacturing | Approved | None posted |
| Oct 24, 1985 | Supplement 9Manufacturing | Approved | None posted |
| Oct 24, 1985 | Supplement 10Manufacturing | Approved | None posted |
| May 18, 1984 | 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
