ANDA 212033, held by Yichang Humanwell. Naproxen Sodium.
As of Nov 15, 2026, ANDA 212033 (Naproxen Sodium), held by Yichang Humanwell, was first approved by FDA on Aug 30, 2019, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen Sodium220MG ยท tablet;oral | Naproxen Sodium | OTC |
| Feb 29, 2020 | Supplement 1Manufacturing | Approved | None posted |
| Aug 30, 2019 | 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
