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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 210180

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NDA 210180 describes APIXABAN, which is a drug marketed by Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Bionpharma, Breckenridge, Hetero Labs Ltd V, Impax, Macleods Pharms Ltd, Micro Labs, Mylan, Regcon Holdings, Torrent, and Zydus Pharms, and is included in thirteen NDAs. It is available from three suppliers. 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. Eleven suppliers are listed for this compound. Additional details are available on the apixaban profile page.

Summary for 210180

Tradename:	APIXABAN
Applicant:	Accord Hlthcare
Ingredient:	apixaban
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Jul 28, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jul 28, 2020	TE:	AB	RLD:	No

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