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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 209898

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NDA 209898 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 209898

Tradename:	APIXABAN
Applicant:	Regcon Holdings
Ingredient:	apixaban
Patents:	0

Pharmacology for NDA: 209898

Mechanism of Action	Factor Xa Inhibitors

Suppliers and Packaging for NDA: 209898

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
APIXABAN	apixaban	TABLET;ORAL	209898	ANDA	Indoco Remedies Limited	14445-149	14445-149-05	500 TABLET, FILM COATED in 1 BOTTLE (14445-149-05)
APIXABAN	apixaban	TABLET;ORAL	209898	ANDA	Indoco Remedies Limited	14445-149	14445-149-10	1 TABLET, FILM COATED in 1 CARTON (14445-149-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Sep 11, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 11, 2020	TE:	AB	RLD:	No

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