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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 four 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. Thirteen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.

Summary for NDA: 020905

Sanofi Aventis Us
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
TABLET;ORAL 020905 NDA sanofi-aventis U.S. LLC 0088-2160 0088-2160-30 30 TABLET, FILM COATED in 1 BOTTLE (0088-2160-30)
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:No

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 Us
TABLET;ORAL020905-002Sep 10, 19984,351,841► subscribe
Sanofi Aventis Us
TABLET;ORAL020905-001Sep 10, 19984,284,786► subscribe
Sanofi Aventis Us
TABLET;ORAL020905-003Sep 10, 19984,351,841► subscribe
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