ANDA 216064, held by Lupin. Valbenazine Tosylate.
As of Nov 15, 2026, ANDA 216064 (Valbenazine Tosylate), held by Lupin, was first approved by FDA on Apr 5, 2024, with 0 approved supplements and 0 published complete response letters.
| Apr 5, 2024 | Original application | Tentative approval | |
| Apr 5, 2024 | Original application | Approved |
| Valbenazine TosylateEQ 40MG BASE · capsule;oral | Valbenazine Tosylate | Rx |
| Valbenazine TosylateEQ 80MG BASE · capsule;oral | Valbenazine Tosylate | Rx |
| Valbenazine TosylateEQ 60MG BASE · capsule;oral | Valbenazine Tosylate | Rx |
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
