ANDA 211065, held by Hetero Labs Ltd V. Naproxen Sodium.
As of Nov 15, 2026, ANDA 211065 (Naproxen Sodium), held by Hetero Labs Ltd V, was first approved by FDA on Oct 28, 2022, with 0 approved supplements and 0 published complete response letters.
USE(S)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen Sodium220MG · tablet;oral | Naproxen Sodium | OTC |
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
