ANDA 209739, held by Hikma. Tetrabenazine.
As of Nov 15, 2026, ANDA 209739 (Tetrabenazine), held by Hikma, was first approved by FDA on Apr 8, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 8, 2019 | Original application | Approved | None posted |
| Tetrabenazine12.5MG · tablet;oral | Tetrabenazine | Discontinued |
| Tetrabenazine25MG · tablet;oral | Tetrabenazine | 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
