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Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077083

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NDA 077083 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 077083
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

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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