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Generated: April 23, 2018

DrugPatentWatch Database Preview

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 three suppliers. 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. Twenty-two 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021759
Suppliers and Packaging for NDA: 021759
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELOXATIN oxaliplatin INJECTABLE;IV (INFUSION) 021759 NDA sanofi-aventis U.S. LLC 0024-0590 N 0024-0590-10
ELOXATIN oxaliplatin INJECTABLE;IV (INFUSION) 021759 NDA sanofi-aventis U.S. LLC 0024-0591 N 0024-0591-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/10ML (5MG/ML)
Approval Date:Jan 31, 2005TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/20ML (5MG/ML)
Approval Date:Jan 31, 2005TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;IV (INFUSION)Strength200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 17, 2006TE:RLD:Yes

Expired US Patents for NDA 021759

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;IV (INFUSION) 021759-003 Nov 17, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;IV (INFUSION) 021759-002 Jan 31, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;IV (INFUSION) 021759-001 Jan 31, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;IV (INFUSION) 021759-001 Jan 31, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Argus Health
Daiichi Sankyo
Harvard Business School
Deloitte
Fuji
Fish and Richardson
Cantor Fitzgerald

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