ANDA 215399, held by Amneal. Indomethacin.
As of Nov 15, 2026, ANDA 215399 (Indomethacin), held by Amneal, was first approved by FDA on Feb 24, 2025, with 0 approved supplements and 0 published complete response letters.
Indomethacin suppositories 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) Acute gouty arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Indomethacin50MG · suppository;rectal | Indomethacin | Rx |
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
