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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Express Scripts
Citi
Chubb
Harvard Business School
UBS
McKesson
Daiichi Sankyo

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:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 13, 2005TE:ABRLD:No

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Daiichi Sankyo
Mallinckrodt
US Department of Justice
Fish and Richardson
Chubb
AstraZeneca
Moodys

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