Treats chorea associated with Huntington's disease. ANDA 206129, held by Sun Pharm. Tetrabenazine.
As of Nov 15, 2026, ANDA 206129 (Tetrabenazine), held by Sun Pharm, was first approved by FDA on Aug 17, 2015, with 2 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 |
|---|---|---|---|
| Aug 17, 2015 | Original application | Approved |
| Tetrabenazine12.5MG · tablet;oral | Tetrabenazine | Discontinued |
| Tetrabenazine25MG · tablet;oral | Tetrabenazine | Discontinued |
| May 18, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 4, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 17, 2015 | 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
