ANDA 214463, held by Patheon Softgels. Naproxen Sodium.
As of Nov 15, 2026, ANDA 214463 (Naproxen Sodium), held by Patheon Softgels, was first approved by FDA on Jan 10, 2023, 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 |
|---|---|---|---|
| Jan 10, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen SodiumEQ 200MG BASE · capsule;oral | Naproxen Sodium | OTC |
| Aug 9, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 10, 2023 | 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
