Treats chorea associated with Huntington’s disease. ANDA 207682, held by Mylan. Tetrabenazine.
As of Nov 15, 2026, ANDA 207682 (Tetrabenazine), held by Mylan, was first approved by FDA on Jan 31, 2017, 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 |
|---|---|---|---|
| Jan 31, 2017 | Original application | Approved | None posted |
| Tetrabenazine12.5MG · tablet;oral | Tetrabenazine | Rx |
| Tetrabenazine25MG · tablet;oral | Tetrabenazine | Rx |
| Jan 6, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 31, 2017 | 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
