ANDA 220314, held by Apotex Inc. Semaglutide.
As of Nov 15, 2026, ANDA 220314 (Semaglutide), held by Apotex Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 2026 | Original application | Tentative approval | None posted |
| Semaglutide2MG/3ML · injection;solution | Semaglutide | None (tentative approval) |
| Semaglutide4MG/3ML · injection;solution | Semaglutide | None (tentative approval) |
| Semaglutide8MG/3ML · injection;solution | Semaglutide | None (tentative approval) |
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
