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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Farmers Insurance
Federal Trade Commission
Chinese Patent Office
Express Scripts

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091369

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NDA 091369 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 091369
Applicant:Alembic Pharms Ltd
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091369
Suppliers and Packaging for NDA: 091369
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEFLUNOMIDE leflunomide TABLET;ORAL 091369 ANDA Trigen Laboratories, LLC 13811-677 N 13811-677-10
LEFLUNOMIDE leflunomide TABLET;ORAL 091369 ANDA Trigen Laboratories, LLC 13811-677 N 13811-677-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 21, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 21, 2011TE:ABRLD:No

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Fish and Richardson
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