Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021759

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ELOXATIN (OXALIPLATIN)
50MG/10ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: OXALIPLATIN
Proprietary Name: ELOXATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 50MG/10ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021759
Product Number: 001
Approval Date: Jan 31, 2005
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ELOXATIN (OXALIPLATIN)
100MG/20ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: OXALIPLATIN
Proprietary Name: ELOXATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 100MG/20ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021759
Product Number: 002
Approval Date: Jan 31, 2005
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ELOXATIN (OXALIPLATIN)
200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: OXALIPLATIN
Proprietary Name: ELOXATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021759
Product Number: 003
Approval Date: Nov 17, 2006
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information