Last Updated: November 13, 2026

Details for New Drug Application (NDA): 210067

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NDA 210067 describes APIXABAN, which is a drug marketed by Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Bionpharma, Breckenridge, Hetero Labs Ltd V, Impax, Macleods Pharms, Micro Labs, Mylan, Regcon Holdings, Torrent, and Zydus Pharms, and is included in thirteen NDAs. It is available from two suppliers. Additional details are available on the APIXABAN profile page.

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

Summary for 210067

Tradename:	APIXABAN
Applicant:	Macleods 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, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 27, 2025	TE:		RLD:	No

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