ANDA 76544, held by Able. Naproxen Sodium.
As of Nov 15, 2026, ANDA 76544 (Naproxen Sodium), held by Able, was first approved by FDA on Aug 22, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2003 | Original application | Approved | None posted |
| Naproxen SodiumEQ 250MG BASE · tablet;oral | Naproxen Sodium | Discontinued |
| Naproxen SodiumEQ 500MG BASE · tablet;oral | Naproxen Sodium | Discontinued |
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
