ANDA 91432, held by Nuvo Pharms Inc. Naproxen.
As of Nov 14, 2026, ANDA 91432 (Naproxen), held by Nuvo Pharms Inc, was first approved by FDA on Sep 19, 2011, 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 Naproxen delayed-release tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 19, 2011 | Original application | Approved | None posted |
| Mar 8, 2023 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 25, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 25, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 25, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 4, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 19, 2011 | 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
