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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Army
AstraZeneca
Johnson and Johnson
Argus Health
Dow
Chubb
Cerilliant
Baxter

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077087

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NDA 077087 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 ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.
Summary for 077087
Tradename:LEFLUNOMIDE
Applicant:Fosun Pharma
Ingredient:leflunomide
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077087
Suppliers and Packaging for NDA: 077087
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEFLUNOMIDE leflunomide TABLET;ORAL 077087 ANDA Physicians Total Care, Inc. 54868-2319 E 54868-2319-0
LEFLUNOMIDE leflunomide TABLET;ORAL 077087 ANDA Physicians Total Care, Inc. 54868-6170 E 54868-6170-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Sep 13, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Sep 13, 2005TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Merck
Deloitte
Fuji
Medtronic
UBS
Moodys
Colorcon

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