Treats chorea associated with Huntington's disease. ANDA 206093, held by Apotex. Tetrabenazine.
As of Nov 15, 2026, ANDA 206093 (Tetrabenazine), held by Apotex, was first approved by FDA on Mar 17, 2020, 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 |
|---|---|---|---|
| Mar 17, 2020 | Original application | Approved | None posted |
| Tetrabenazine12.5MG · tablet;oral | Tetrabenazine | Rx |
| Tetrabenazine25MG · tablet;oral | Tetrabenazine | Rx |
| May 19, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 17, 2020 | Original application | Approved | None posted |
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
