Treats chorea associated with Huntington's disease. ANDA 204574, held by Hetero Labs Ltd V. Tetrabenazine.
As of Nov 15, 2026, ANDA 204574 (Tetrabenazine), held by Hetero Labs Ltd V, was first approved by FDA on Feb 3, 2016, with 1 approved supplement and 0 published complete response letters.
Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 2016 | Original application | Approved |
| Tetrabenazine12.5MG · tablet;oral | Tetrabenazine | Rx |
| Tetrabenazine25MG · tablet;oral | Tetrabenazine | Rx |
| Jan 4, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 3, 2016 | Original application | Approved |
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
