ANDA 208363, held by Puracap Pharm LLC. Naproxen Sodium.
As of Nov 15, 2026, ANDA 208363 (Naproxen Sodium), held by Puracap Pharm LLC, was first approved by FDA on Mar 15, 2018, with 1 approved supplement 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 |
|---|---|---|---|
| Mar 15, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen SodiumEQ 200MG BASE · capsule;oral | Naproxen Sodium | OTC |
| Dec 13, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 15, 2018 | 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
