Last Updated: September 24, 2026

Details for New Drug Application (NDA): 077083

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NDA 077083 describes LEFLUNOMIDE, which is a drug marketed by Abhai Llc, Aet Pharma, Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Barr, Fosun Wanbang, Heritage, Lupin, Sandoz, Teva Pharms, and Zydus Lifesciences, and is included in twelve NDAs. It is available from sixteen suppliers. Additional details are available on the LEFLUNOMIDE profile page.

The generic ingredient in LEFLUNOMIDE is leflunomide. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.

Summary for 077083

Tradename:	LEFLUNOMIDE
Applicant:	Barr
Ingredient:	leflunomide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 13, 2005	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Sep 13, 2005	TE:		RLD:	No

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