NDA 18185, held by Zyla. Indomethacin.
As of Nov 14, 2026, NDA 18185 (Indocin Sr), held by Zyla, was first approved by FDA on Feb 23, 1982, with 42 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 1982 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indocin Sr75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, extended release;oral | Indomethacin | DiscontinuedReference drug |
| Nov 21, 2024 | Supplement 59Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 58Labeling · Standard review | Approved | |
| Mar 26, 2019 | Supplement 57Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 56Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 55Labeling · Standard review | Approved | |
| Oct 31, 2001 | Supplement 48Labeling · Standard review | Approved | None posted |
| Oct 11, 2001 | Supplement 53Labeling · Standard review | Approved | None posted |
| Oct 7, 1997 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1996 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1994 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1994 | Supplement 47Labeling · Standard review | Approved | None posted |
| Sep 26, 1994 | Supplement 41Labeling · Standard review | Approved | None posted |
| Sep 14, 1994 | Supplement 45Labeling · Standard review | Approved | None posted |
| Sep 14, 1994 | Supplement 42Labeling · Standard review | Approved | None posted |
| Sep 13, 1994 | Supplement 46Labeling · Standard review | Approved | None posted |
| Aug 18, 1994 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| May 25, 1989 | Supplement 38Labeling | Approved | None posted |
| Feb 10, 1989 | Supplement 31Labeling | Approved | None posted |
| Jan 9, 1989 | Supplement 35Labeling | Approved | None posted |
| Jan 6, 1989 | Supplement 37Labeling | Approved | None posted |
| Jan 6, 1989 | Supplement 33Labeling | Approved | None posted |
| Jun 3, 1988 | Supplement 30Labeling | Approved | None posted |
| Mar 10, 1988 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1986 | Supplement 26Labeling | Approved | None posted |
| Aug 15, 1986 | Supplement 24Labeling | Approved | None posted |
| Jan 6, 1986 | Supplement 11Labeling | Approved | None posted |
| Sep 30, 1985 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jul 23, 1985 | Supplement 22Labeling | Approved | None posted |
| Feb 21, 1985 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Feb 21, 1985 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1984 | Supplement 21Labeling | Approved | None posted |
| Nov 27, 1984 | Supplement 15Labeling | Approved | None posted |
| Nov 20, 1984 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Oct 5, 1984 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 3, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 25, 1984 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 3, 1984 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1983 | Supplement 8Labeling | Approved | None posted |
| Feb 1, 1983 | Supplement 6Labeling | Approved | None posted |
| Feb 1, 1983 | Supplement 5Labeling | Approved | None posted |
| Feb 1, 1983 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 19, 1982 | Supplement 4Labeling | Approved | None posted |
| Feb 23, 1982 | Original applicationNew dosage form · Standard review | 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
