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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 213758

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NDA 213758 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 Ltd, Sandoz, Teva Pharms Usa Inc, and Zydus Pharms, and is included in twelve NDAs. It is available from two suppliers. Additional details are available on the BREXPIPRAZOLE profile page.

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

Summary for 213758

Tradename:	BREXPIPRAZOLE
Applicant:	Chartwell Rx
Ingredient:	brexpiprazole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Oct 25, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Oct 25, 2023	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 25, 2023	TE:		RLD:	No

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