Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 6, 2019

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 two suppliers. Additional details are available on the ARAVA profile page.

The generic ingredient in ARAVA is leflunomide. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leflunomide profile page.
Summary for 020905
Tradename:ARAVA
Applicant:Sanofi Aventis Us
Ingredient:leflunomide
Patents:0
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)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Expired US Patents for NDA 020905

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-001 Sep 10, 1998   Start Trial   Start Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-002 Sep 10, 1998   Start Trial   Start Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-003 Sep 10, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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