Details for New Drug Application (NDA): 216064
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NDA 216064 describes VALBENAZINE TOSYLATE, which is a drug marketed by Lupin and Zydus Lifesciences and is included in two NDAs. Additional details are available on the VALBENAZINE TOSYLATE profile page.
The generic ingredient in VALBENAZINE TOSYLATE is valbenazine tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
The generic ingredient in VALBENAZINE TOSYLATE is valbenazine tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
Summary for 216064
| Tradename: | VALBENAZINE TOSYLATE |
| Applicant: | Lupin |
| Ingredient: | valbenazine tosylate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Apr 5, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 80MG BASE | ||||
| Approval Date: | Apr 5, 2024 | TE: | AB | RLD: | No | ||||
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