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. Seventeen 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

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	1 BOTTLE in 1 CARTON (0088-2160-30) / 30 TABLET, FILM COATED in 1 BOTTLE
ARAVA	leflunomide	TABLET;ORAL	020905	NDA	sanofi-aventis U.S. LLC	0088-2161	0088-2161-30	1 BOTTLE in 1 CARTON (0088-2161-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 10, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Sep 10, 1998	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 10, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020905

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

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