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Last Updated: December 15, 2025

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 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 210067

Tradename:	APIXABAN
Applicant:	Macleods Pharms Ltd
Ingredient:	apixaban
Patents:	0

Pharmacology for NDA: 210067

Mechanism of Action	Factor Xa Inhibitors

Suppliers and Packaging for NDA: 210067

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
APIXABAN	apixaban	TABLET;ORAL	210067	ANDA	Macleods Pharmaceuticals Limited	33342-337	33342-337-09	60 TABLET, FILM COATED in 1 BOTTLE (33342-337-09)
APIXABAN	apixaban	TABLET;ORAL	210067	ANDA	Macleods Pharmaceuticals Limited	33342-337	33342-337-12	10 BLISTER PACK in 1 CARTON (33342-337-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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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