ANDA 215971, held by Aurobindo Pharma Ltd. Deutetrabenazine.
As of Nov 15, 2026, ANDA 215971 (Deutetrabenazine), held by Aurobindo Pharma Ltd, was first approved by FDA on Dec 26, 2024, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 26, 2024 | Original application | Approved |
| Deutetrabenazine6MG · tablet;oral | Deutetrabenazine | Discontinued |
| Deutetrabenazine9MG · tablet;oral | Deutetrabenazine | Discontinued |
| Deutetrabenazine12MG · tablet;oral | Deutetrabenazine | Discontinued |
| May 1, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 26, 2024 | 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
