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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218195

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NDA 218195 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 218195

Tradename:	RIVAROXABAN
Applicant:	Lupin Ltd
Ingredient:	rivaroxaban
Patents:	0

Pharmacology for NDA: 218195

Mechanism of Action	Factor Xa Inhibitors

Medical Subject Heading (MeSH) Categories for 218195

Factor Xa Inhibitors

Suppliers and Packaging for NDA: 218195

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIVAROXABAN	rivaroxaban	FOR SUSPENSION;ORAL	218195	ANDA	Lupin Pharmaceuticals, Inc.	70748-355	70748-355-01	1 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	1MG/ML
Approval Date:	Sep 25, 2025	TE:	AB	RLD:	No

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