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Serving leading biopharmaceutical companies globally:

Moodys
Cerilliant
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Argus Health
Covington
Healthtrust
Merck
US Department of Justice

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020905

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NDA 020905 describes ARAVA, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from three suppliers. Additional details are available on the ARAVA profile page.

The generic ingredient in ARAVA is leflunomide. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the leflunomide profile page.

Summary for 020905

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020905

Suppliers and Packaging for NDA: 020905

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARAVA leflunomide TABLET;ORAL 020905 NDA sanofi-aventis U.S. LLC 0088-2160 0088-2160-30 30 TABLET, FILM COATED in 1 BOTTLE (0088-2160-30)
ARAVA leflunomide TABLET;ORAL 020905 NDA sanofi-aventis U.S. LLC 0088-2161 0088-2161-30 30 TABLET, FILM COATED in 1 BOTTLE (0088-2161-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 10, 1998TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 10, 1998TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 10, 1998TE:RLD:Yes

Expired Orange Book Patents for NDA: 020905

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis UsARAVAleflunomideTABLET;ORAL020905-003Sep 10, 1998► Subscribe► Subscribe
Sanofi Aventis UsARAVAleflunomideTABLET;ORAL020905-001Sep 10, 1998► Subscribe► Subscribe
Sanofi Aventis UsARAVAleflunomideTABLET;ORAL020905-003Sep 10, 1998► Subscribe► Subscribe
Sanofi Aventis UsARAVAleflunomideTABLET;ORAL020905-003Sep 10, 1998► Subscribe► Subscribe
Sanofi Aventis UsARAVAleflunomideTABLET;ORAL020905-002Sep 10, 1998► Subscribe► Subscribe
Sanofi Aventis UsARAVAleflunomideTABLET;ORAL020905-002Sep 10, 1998► Subscribe► Subscribe
Sanofi Aventis UsARAVAleflunomideTABLET;ORAL020905-002Sep 10, 1998► Subscribe► Subscribe
Sanofi Aventis UsARAVAleflunomideTABLET;ORAL020905-001Sep 10, 1998► Subscribe► Subscribe
Sanofi Aventis UsARAVAleflunomideTABLET;ORAL020905-001Sep 10, 1998► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Healthtrust
Novartis
Chubb
Queensland Health
Johnson and Johnson
McKesson
Harvard Business School
Chinese Patent Office
US Department of Justice
Cipla

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