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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 211863

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NDA 211863 describes LEFLUNOMIDE, which is a drug marketed by Abhai Llc, Aet Pharma, Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Barr, Fosun Wanbang, Heritage, Lupin Ltd, 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 are seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.

Summary for 211863

Tradename:	LEFLUNOMIDE
Applicant:	Lupin Ltd
Ingredient:	leflunomide
Patents:	0

Pharmacology for NDA: 211863

Suppliers and Packaging for NDA: 211863

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEFLUNOMIDE	leflunomide	TABLET;ORAL	211863	ANDA	NuCare Pharmaceuticals, Inc.	68071-3763	68071-3763-9	1 BOTTLE in 1 CARTON (68071-3763-9) / 90 TABLET, FILM COATED in 1 BOTTLE
LEFLUNOMIDE	leflunomide	TABLET;ORAL	211863	ANDA	Lupin Pharmaceuticals, Inc.	70748-129	70748-129-06	30 TABLET, FILM COATED in 1 BOTTLE (70748-129-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 4, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Feb 4, 2020	TE:	AB	RLD:	No

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