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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 210185

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NDA 210185 describes APIXABAN, which is a drug marketed by Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Bionpharma, Breckenridge, Hetero Labs Ltd V, Indoco, Micro Labs, Mylan, and Zydus Pharms, and is included in ten NDAs. It is available from one supplier. Additional details are available on the APIXABAN profile page.

The generic ingredient in APIXABAN is apixaban. There are thirty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the apixaban profile page.

Summary for 210185

Tradename:	APIXABAN
Applicant:	Zydus Pharms
Ingredient:	apixaban
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Feb 27, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 27, 2023	TE:		RLD:	No

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