Last Updated: September 28, 2026

Details for New Drug Application (NDA): 213782

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NDA 213782 describes BREXPIPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd V, Lupin, Sandoz, Teva Pharms Usa Inc, and Zydus Pharms, and is included in twelve NDAs. It is available from one supplier. Additional details are available on the BREXPIPRAZOLE profile page.

The generic ingredient in BREXPIPRAZOLE is brexpiprazole. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.

Summary for 213782

Tradename:	BREXPIPRAZOLE
Applicant:	Alkem Labs Ltd
Ingredient:	brexpiprazole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Nov 28, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Nov 28, 2023	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Nov 28, 2023	TE:		RLD:	No

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