ANDA 205497, held by Aurobindo Pharma Ltd. Naproxen Sodium.
As of Nov 15, 2026, ANDA 205497 (Naproxen Sodium), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 18, 2016, with 0 approved supplements and 0 published complete response letters.
Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen Sodium220MG · tablet;oral | Naproxen Sodium | OTC |
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
