Details for New Drug Application (NDA): 021759

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NDA 021759 describes ELOXATIN, which is a drug marketed by Sanofi Aventis Us and is included in two NDAs. It is available from one supplier. Additional details are available on the ELOXATIN profile page.

The generic ingredient in ELOXATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.

Summary for 021759

Tradename:	ELOXATIN
Applicant:	Sanofi Aventis Us
Ingredient:	oxaliplatin
Patents:	0

Suppliers and Packaging for NDA: 021759

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1727	0955-1727-20	1 VIAL, GLASS in 1 CARTON (0955-1727-20) / 20 mL in 1 VIAL, GLASS
ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1731	0955-1731-10	1 VIAL, GLASS in 1 CARTON (0955-1731-10) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Jan 31, 2005	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	100MG/20ML (5MG/ML)
Approval Date:	Jan 31, 2005	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 17, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021759

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-002	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-002	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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