Treats chorea associated with Huntington’s disease. ANDA 213621, held by Ajanta Pharma Ltd. Tetrabenazine.
As of Nov 15, 2026, ANDA 213621 (Tetrabenazine), held by Ajanta Pharma Ltd, was first approved by FDA on Dec 4, 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 |
|---|---|---|---|
| Dec 4, 2020 | 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
