Last Updated: May 3, 2026

Details for New Drug Application (NDA): 218427

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NDA 218427 describes RIVAROXABAN, which is a drug marketed by Alkem Labs Ltd, Apotex, Lupin Ltd, Aiping Pharm Inc, Alembic, Ascent Pharms Inc, Aurobindo Pharma Ltd, Biocon Pharma, Breckenridge, Dr Reddys, Invagen Pharms, Macleods Pharms Ltd, MSN, Regcon Holdings, Sciegen Pharms, Sunshine, and Taro, and is included in twenty-one NDAs. It is available from seventeen 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. Twenty-one suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.

Summary for 218427

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

Medical Subject Heading (MeSH) Categories for 218427

Factor Xa Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	1MG/ML
Approval Date:	Mar 2, 2026	TE:	AB	RLD:	No

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