ANDA 213195, held by Teva Pharms USA Inc. Naltrexone.
As of Nov 14, 2026, ANDA 213195 (Naltrexone), held by Teva Pharms USA Inc, was first approved by FDA on Jul 6, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 6, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naltrexone380MG/VIAL ยท for suspension, extended release;intramuscular | Naltrexone | 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
