ANDA 211353, held by Teva Pharms USA Inc. Sofosbuvir.
As of Nov 14, 2026, ANDA 211353 (Sofosbuvir), held by Teva Pharms USA Inc, was first approved by FDA on Jan 27, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sofosbuvir400MG ยท tablet;oral | Sofosbuvir | 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
