ANDA 207612, held by Novelgenix Theraps. Naproxen Sodium.
As of Nov 15, 2026, ANDA 207612 (Naproxen Sodium), held by Novelgenix Theraps, was first approved by FDA on Nov 16, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen Sodium220MG ยท tablet;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
