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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077086

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NDA 077086 describes LEFLUNOMIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Barr, Fosun Pharma, Heritage Pharms Inc, Sandoz, and Teva Pharms, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the LEFLUNOMIDE profile page.

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

Summary for 077086

Tradename:	LEFLUNOMIDE
Applicant:	Heritage Pharms Inc
Ingredient:	leflunomide
Patents:	0
Therapeutic Class:	Immunological Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 077086

Suppliers and Packaging for NDA: 077086

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEFLUNOMIDE	leflunomide	TABLET;ORAL	077086	ANDA	Heritage Pharmaceuticals Inc	23155-043	N	23155-043-05
LEFLUNOMIDE	leflunomide	TABLET;ORAL	077086	ANDA	Heritage Pharmaceuticals Inc	23155-043	N	23155-043-03

Profile for product number 001

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

Profile for product number 002

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

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