Treats chorea associated with Huntington’s disease. ANDA 209284, held by Dr Reddys. Tetrabenazine.
As of Nov 15, 2026, ANDA 209284 (Tetrabenazine), held by Dr Reddys, was first approved by FDA on Jan 8, 2018, 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 8, 2018 | 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
