ANDA 216184, held by Zydus Lifesciences. Indomethacin.
As of Nov 15, 2026, ANDA 216184 (Indomethacin), held by Zydus Lifesciences, was first approved by FDA on Aug 2, 2023, with 1 approved supplement and 0 published complete response letters.
Indomethacin 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 2, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indomethacin50MG · suppository;rectal | Indomethacin | Rx |
| Nov 21, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 2, 2023 | 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
