ANDA 91183, held by Sun Pharm Inds Ltd. Naproxen Sodium.
As of Nov 15, 2026, ANDA 91183 (Naproxen Sodium), held by Sun Pharm Inds Ltd, was first approved by FDA on May 20, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2011 | 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
