ANDA 200629, held by Aurobindo Pharma Ltd. Naproxen Sodium.
As of Nov 15, 2026, ANDA 200629 (Naproxen Sodium), held by Aurobindo Pharma Ltd, was first approved by FDA on Oct 31, 2011, with 7 approved supplements and 0 published complete response letters.
Naproxen sodium 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 |
|---|---|---|---|
| Oct 31, 2011 | Original application | Approved | None posted |
| Naproxen SodiumEQ 250MG BASE · tablet;oral | Naproxen Sodium | Rx |
| Naproxen SodiumEQ 500MG BASE · tablet;oral | Naproxen Sodium | Rx |
| Jul 24, 2025 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 24, 2025 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jul 24, 2025 | Supplement 18Labeling · Standard review | Approved | None posted |
| Dec 6, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 6, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 6, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 2, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 31, 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
