ANDA 205258, held by Apotex. Nevirapine.
As of Nov 15, 2026, ANDA 205258 (Nevirapine), held by Apotex, was first approved by FDA on Apr 3, 2014, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 3, 2014 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nevirapine400MG ยท tablet, extended release;oral | Nevirapine | 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
