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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208543

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NDA 208543 describes RIVAROXABAN, which is a drug marketed by Alkem Labs Ltd, Lupin Ltd, Aiping Pharm Inc, Alembic, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Biocon Pharma, Breckenridge, Dr Reddys, Invagen Pharms, Macleods Pharms Ltd, MSN, Regcon Holdings, Sciegen Pharms Inc, Sunshine, and Taro, and is included in eighteen NDAs. It is available from fourteen suppliers. Additional details are available on the RIVAROXABAN profile page.

The generic ingredient in RIVAROXABAN is rivaroxaban. There are thirty-five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.

Summary for 208543

Tradename:	RIVAROXABAN
Applicant:	Invagen Pharms
Ingredient:	rivaroxaban
Patents:	0

Medical Subject Heading (MeSH) Categories for 208543

Factor Xa Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 14, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	May 14, 2025	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	May 14, 2025	TE:		RLD:	No

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