ANDA 73314, held by Cosette. Indomethacin.
As of Nov 15, 2026, ANDA 73314 (Indomethacin), held by Cosette, was first approved by FDA on Aug 31, 1992, with 9 approved supplements and 0 published complete response letters.
INDOCIN Suppository is indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 1992 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indomethacin50MG · suppository;rectal | Indomethacin | Rx |
| Nov 21, 2024 | Supplement 29Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 25Labeling · Standard review | Approved | None posted |
| Sep 11, 2019 | Supplement 22Labeling · Standard review | Approved | None posted |
| Sep 11, 2019 | Supplement 23Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 16Labeling · Standard review | Approved | None posted |
| Apr 29, 2011 | Supplement 12Labeling | Approved | None posted |
| Mar 13, 2006 | Supplement 7Labeling | Approved | None posted |
| Jan 28, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Mar 4, 1993 | Supplement 1Labeling | Approved | None posted |
| Aug 31, 1992 | 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
