Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213477
Company: ZENARA

Products on ANDA 213477

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BREXPIPRAZOLE	BREXPIPRAZOLE	0.25MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	0.5MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	1MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	2MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	3MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	4MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213477

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2022	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213477Orig1s000TAltr.pdf