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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Harvard Business School

Generated: February 24, 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 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 077086
Applicant:Heritage Pharms Inc
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:

Daiichi Sankyo
Fish and Richardson
Queensland Health
Johnson and Johnson
US Army

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