Relieves mild to moderate pain. ANDA 75416, held by Actavis Labs Fl Inc. Naproxen Sodium.
As of Nov 15, 2026, ANDA 75416 (Naproxen Sodium), held by Actavis Labs Fl Inc, was first approved by FDA on Aug 27, 2002, with 10 approved supplements and 0 published complete response letters.
Naproxen sodium extended-release tablets are indicated for the treatment of: rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2002 | Original application | Approved |
| Naproxen SodiumEQ 500MG BASE · tablet, extended release;oral | Naproxen Sodium | Rx |
| Naproxen SodiumEQ 375MG BASE · tablet, extended release;oral | Naproxen Sodium | Rx |
| Naproxen SodiumEQ 750MG BASE · tablet, extended release;oral | Naproxen Sodium | Rx |
| Oct 19, 2026 | Supplement 24Labeling · Standard review | Approved | None posted |
| Aug 22, 2024 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 25, 2019 | Supplement 19Labeling · Standard review | Approved | None posted |
| Sep 8, 2016 | Supplement 16Labeling · Standard review | Approved | None posted |
| Apr 15, 2015 | Supplement 12Labeling · Standard review | Approved | None posted |
| Feb 21, 2008 | Supplement 8Labeling | Approved | None posted |
| Apr 3, 2007 | Supplement 6Labeling | Approved | None posted |
| Apr 23, 2003 | Supplement 2Labeling | Approved | None posted |
| Apr 23, 2003 | Supplement 3Manufacturing | Approved | None posted |
| Mar 21, 2003 | Supplement 1Manufacturing | Approved | None posted |
| Aug 27, 2002 | 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
