ANDA 78250, held by Glenmark Pharms Ltd. Naproxen.
As of Nov 14, 2026, ANDA 78250 (Naproxen), held by Glenmark Pharms Ltd, was first approved by FDA on Mar 28, 2007, with 6 approved supplements and 0 published complete response letters.
Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2007 | Original application | Approved | None posted |
| Jul 28, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jul 28, 2020 | Supplement 16Labeling · Standard review | Approved | None posted |
| Jul 28, 2020 | Supplement 18Labeling · Standard review | Approved | None posted |
| Apr 13, 2015 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 8, 2011 | Supplement 8Labeling | Approved | None posted |
| Sep 8, 2008 | Supplement 2Labeling | Approved | None posted |
| Mar 28, 2007 | 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
