Last Updated: June 24, 2026

Details for New Drug Application (NDA): 213652

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NDA 213652 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 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 213652

Tradename:	LEFLUNOMIDE
Applicant:	Aurobindo Pharma
Ingredient:	leflunomide
Patents:	0

Pharmacology for NDA: 213652

Suppliers and Packaging for NDA: 213652

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEFLUNOMIDE	leflunomide	TABLET;ORAL	213652	ANDA	A-S Medication Solutions	50090-5992	50090-5992-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-5992-0)
LEFLUNOMIDE	leflunomide	TABLET;ORAL	213652	ANDA	Aurobindo Pharma Limited	59651-348	59651-348-30	30 TABLET, FILM COATED in 1 BOTTLE (59651-348-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 29, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Mar 29, 2021	TE:	AB	RLD:	No

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