Details for New Drug Application (NDA): 021492

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NDA 021492 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 021492

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 9, 2002	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 9, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021492

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-001	Aug 9, 2002	5,290,961*PED	⤷ Get Started Free
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-002	Aug 9, 2002	5,420,319*PED	⤷ Get Started Free
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-002	Aug 9, 2002	5,290,961*PED	⤷ Get Started Free
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-002	Aug 9, 2002	5,338,874*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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