Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216064
Company: LUPIN LTD

Products on ANDA 216064

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 60MG BASE	CAPSULE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216064

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2024	ORIG-2	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216064Orig1s000TA_ltr.pdf
04/05/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216064Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 216064

VALBENAZINE TOSYLATE

CAPSULE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INGREZZA	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	209241	NEUROCRINE
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	216064	LUPIN LTD

CAPSULE;ORAL; EQ 80MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INGREZZA	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	209241	NEUROCRINE
VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE;ORAL	Prescription	No	AB	216064	LUPIN LTD