ANDA 75927, held by Amneal Pharms Ny. Naproxen.
As of Nov 14, 2026, ANDA 75927 (Naproxen), held by Amneal Pharms Ny, was first approved by FDA on Dec 18, 2001, with 11 approved supplements and 0 published complete response letters.
Naproxen tablets are 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 |
|---|---|---|---|
| Dec 18, 2001 | Original application | Approved | None posted |
| Mar 13, 2025 | Supplement 43Labeling · Standard review | Approved | None posted |
| Mar 13, 2025 | Supplement 42Labeling · Standard review | Approved | None posted |
| Mar 13, 2025 | Supplement 38Labeling · Standard review | Approved | None posted |
| Mar 13, 2025 | Supplement 35Labeling · Standard review | Approved | None posted |
| Nov 22, 2019 | Supplement 31Labeling · Standard review | Approved | None posted |
| Nov 22, 2019 | Supplement 27Labeling · Standard review | Approved | None posted |
| Nov 22, 2019 | Supplement 25Labeling · Standard review | Approved | None posted |
| Nov 2, 2014 | Supplement 21Labeling · Standard review | Approved | None posted |
| Oct 16, 2007 | Supplement 11Labeling | Approved | None posted |
| May 19, 2006 | Supplement 6Labeling | Approved | None posted |
| Nov 20, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Dec 18, 2001 | 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
