Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213782
Company: ALKEM LABS LTD

Products on ANDA 213782

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BREXPIPRAZOLE	BREXPIPRAZOLE	0.25MG	TABLET;ORAL	Prescription	AB	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	0.5MG	TABLET;ORAL	Prescription	AB	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	1MG	TABLET;ORAL	Prescription	AB	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	2MG	TABLET;ORAL	Prescription	AB	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	3MG	TABLET;ORAL	Prescription	AB	No	No
BREXPIPRAZOLE	BREXPIPRAZOLE	4MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213782

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213782Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 213782

BREXPIPRAZOLE

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BREXPIPRAZOLE	BREXPIPRAZOLE	0.25MG	TABLET;ORAL	Prescription	No	AB	213782	ALKEM LABS LTD
BREXPIPRAZOLE	BREXPIPRAZOLE	0.25MG	TABLET;ORAL	Prescription	No	AB	213669	HETERO LABS LTD V
BREXPIPRAZOLE	BREXPIPRAZOLE	0.25MG	TABLET;ORAL	Prescription	No	AB	213758	OPTIMUS
REXULTI	BREXPIPRAZOLE	0.25MG	TABLET;ORAL	Prescription	Yes	AB	205422	OTSUKA