Treats chorea associated with Huntington’s disease. ANDA 213316, held by Piramal. Tetrabenazine.
As of Nov 15, 2026, ANDA 213316 (Tetrabenazine), held by Piramal, was first approved by FDA on Jan 22, 2020, with 0 approved supplements and 0 published complete response letters.
Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 2020 | Original application | Approved | None posted |
| Tetrabenazine12.5MG · tablet;oral | Tetrabenazine | Rx |
| Tetrabenazine25MG · tablet;oral | Tetrabenazine | Rx |
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
