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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 209845

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NDA 209845 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 209845

Tradename:	APIXABAN
Applicant:	Breckenridge
Ingredient:	apixaban
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Jul 26, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jul 26, 2021	TE:		RLD:	No

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