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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212308

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NDA 212308 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 212308

Tradename:	LEFLUNOMIDE
Applicant:	Zydus Lifesciences
Ingredient:	leflunomide
Patents:	0

Pharmacology for NDA: 212308

Suppliers and Packaging for NDA: 212308

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEFLUNOMIDE	leflunomide	TABLET;ORAL	212308	ANDA	A-S Medication Solutions	50090-7537	50090-7537-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-7537-0)
LEFLUNOMIDE	leflunomide	TABLET;ORAL	212308	ANDA	NuCare Pharmaceuticals, Inc.	68071-3764	68071-3764-9	90 TABLET, FILM COATED in 1 BOTTLE (68071-3764-9)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 24, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Apr 24, 2019	TE:	AB	RLD:	No

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