ANDA 75168, held by Dr Reddys Labs Inc. Naproxen Sodium.
As of Nov 15, 2026, ANDA 75168 (Naproxen Sodium), held by Dr Reddys Labs Inc, was first approved by FDA on Jul 28, 1998, with 3 approved supplements and 0 published complete response letters.
Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen Sodium220MG · tablet;oral | Naproxen Sodium | OTC |
| Dec 13, 2010 | Supplement 11Labeling | Approved | None posted |
| Jul 10, 2009 | Supplement 8Labeling | Approved | None posted |
| Mar 16, 2008 | Supplement 5Labeling | Approved | None posted |
| Jul 28, 1998 | 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
