ANDA 215472, held by Onesource. Naproxen Sodium.
As of Nov 15, 2026, ANDA 215472 (Naproxen Sodium), held by Onesource, was first approved by FDA on Aug 17, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 17, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen SodiumEQ 200MG BASE ยท capsule;oral | Naproxen Sodium | Discontinued |
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
