ANDA 75390, held by Aurobindo Pharma USA. Naproxen.
As of Nov 14, 2026, ANDA 75390 (Naproxen), held by Aurobindo Pharma USA, was first approved by FDA on Apr 19, 2001, with 5 approved supplements and 0 published complete response letters.
Naproxen delayed-release tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2001 | Original application | Approved |
| Mar 19, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 19, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 19, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 23, 2008 | Supplement 3Labeling | Approved | None posted |
| Sep 25, 2007 | Supplement 2Labeling | Approved | None posted |
| Apr 19, 2001 | Original application | Approved |
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
