ANDA 216137, held by Zydus Lifesciences. Valbenazine Tosylate.
As of Nov 15, 2026, ANDA 216137 (Valbenazine Tosylate), held by Zydus Lifesciences, was first approved by FDA on Aug 7, 2024, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2024 | Original application | Approved |
| Valbenazine TosylateEQ 40MG BASE · capsule;oral | Valbenazine Tosylate | Discontinued |
| Valbenazine TosylateEQ 60MG BASE · capsule;oral | Valbenazine Tosylate | Discontinued |
| Valbenazine TosylateEQ 80MG BASE · capsule;oral | Valbenazine Tosylate | Discontinued |
| Nov 26, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 7, 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
