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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218502

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NDA 218502 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 218502

Tradename:	RIVAROXABAN
Applicant:	Alkem Labs Ltd
Ingredient:	rivaroxaban
Patents:	0

Pharmacology for NDA: 218502

Mechanism of Action	Factor Xa Inhibitors

Medical Subject Heading (MeSH) Categories for 218502

Factor Xa Inhibitors

Suppliers and Packaging for NDA: 218502

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIVAROXABAN	rivaroxaban	FOR SUSPENSION;ORAL	218502	ANDA	Ascend Laboratories, LLC	67877-882	67877-882-71	1 BOTTLE in 1 CARTON (67877-882-71) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	1MG/ML
Approval Date:	Jun 26, 2025	TE:	AB	RLD:	No

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