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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 217810

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NDA 217810 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 217810

Tradename:	RIVAROXABAN
Applicant:	Apotex
Ingredient:	rivaroxaban
Patents:	0

Pharmacology for NDA: 217810

Mechanism of Action	Factor Xa Inhibitors

Medical Subject Heading (MeSH) Categories for 217810

Factor Xa Inhibitors

Suppliers and Packaging for NDA: 217810

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIVAROXABAN	rivaroxaban	TABLET;ORAL	217810	ANDA	Apotex Corp.	60505-6256	60505-6256-5	500 TABLET, FILM COATED in 1 BOTTLE (60505-6256-5)
RIVAROXABAN	rivaroxaban	TABLET;ORAL	217810	ANDA	Apotex Corp.	60505-6256	60505-6256-6	60 TABLET, FILM COATED in 1 BOTTLE (60505-6256-6)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	May 2, 2025	TE:	AB	RLD:	No

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