ANDA 216504, held by Aurobindo Pharma. Naproxen.
As of Nov 14, 2026, ANDA 216504 (Naproxen), held by Aurobindo Pharma, was first approved by FDA on Oct 3, 2025, with 0 approved supplements and 0 published complete response letters.
Naproxen oral suspension is indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 3, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen25MG/ML · suspension;oral | Naproxen | Discontinued |
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
