Last Updated: September 28, 2026

Details for New Drug Application (NDA): 220874

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NDA 220874 describes RIVAROXABAN, which is a drug marketed by Alkem Labs Ltd, Apotex, Lupin, Aiping Pharm Inc, Alembic, Ascent Pharms Inc, Aurobindo Pharma Ltd, Biocon Pharma, Breckenridge, Dr Reddys, Invagen Pharms, Macleods Pharms, Mankind Pharma, Micro Labs, MSN, Regcon Holdings, Sciegen Pharms, Sunshine, and Taro, and is included in twenty-three NDAs. It is available from nineteen suppliers. Additional details are available on the RIVAROXABAN profile page.

The generic ingredient in RIVAROXABAN is rivaroxaban. There is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.

Summary for 220874

Tradename:	RIVAROXABAN
Applicant:	Mankind Pharma
Ingredient:	rivaroxaban
Patents:	0

Medical Subject Heading (MeSH) Categories for 220874

Factor Xa Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Jul 1, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jul 1, 2026	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jul 1, 2026	TE:	AB	RLD:	No

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