Treats chorea associated with Huntington’s disease. ANDA 208826, held by Bionpharma. Tetrabenazine.
As of Nov 15, 2026, ANDA 208826 (Tetrabenazine), held by Bionpharma, was first approved by FDA on Dec 18, 2017, 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 18, 2017 | 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
