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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 216064

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NDA 216064 describes VALBENAZINE TOSYLATE, which is a drug marketed by Lupin Ltd 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. 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 Ltd
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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