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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 213718

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NDA 213718 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 213718

Tradename:	BREXPIPRAZOLE
Applicant:	Ajanta Pharma Ltd
Ingredient:	brexpiprazole
Patents:	0

Pharmacology for NDA: 213718

Suppliers and Packaging for NDA: 213718

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213718	ANDA	Ajanta Pharma USA Inc.	27241-204	27241-204-30	30 TABLET in 1 BOTTLE (27241-204-30)
BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213718	ANDA	Ajanta Pharma USA Inc.	27241-205	27241-205-30	30 TABLET in 1 BOTTLE (27241-205-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Feb 3, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Feb 3, 2023	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Feb 3, 2023	TE:		RLD:	No

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