ANDA 91549, held by Amneal Pharms. Indomethacin.
As of Nov 15, 2026, ANDA 91549 (Indomethacin), held by Amneal Pharms, was first approved by FDA on Dec 1, 2010, with 8 approved supplements and 0 published complete response letters.
Indomethacin extended-release capsules are 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)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 1, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indomethacin75MG · capsule, extended release;oral | Indomethacin | Rx |
| Nov 21, 2024 | Supplement 18Labeling · Standard review | Approved | None posted |
| Sep 7, 2023 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 13Labeling · Standard review | Approved | None posted |
| Feb 2, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 18, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 18, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 18, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 1, 2010 | 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
