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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078811

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NDA 078811 describes OXALIPLATIN, which is a drug marketed by Accord Hlthcare, Actavis Llc, Actavis Totowa, Cipla Ltd, Eugia Pharma, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira Inc, Hospira Worldwide, Jiangsu Hengrui Med, Luitpold Pharms Inc, Mylan Labs Ltd, Qilu Pharm Co Ltd, Sandoz, Sandoz Inc, Sun Pharma Global, and Teva Pharms, and is included in twenty-five NDAs. It is available from twenty-one suppliers. Additional details are available on the OXALIPLATIN profile page.

The generic ingredient in OXALIPLATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
Summary for 078811
Tradename:OXALIPLATIN
Applicant:Fresenius Kabi Oncol
Ingredient:oxaliplatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078811
Suppliers and Packaging for NDA: 078811
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 078811 ANDA Fresenius Kabi USA, LLC 63323-750 E 63323-750-10
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 078811 ANDA Fresenius Kabi USA, LLC 63323-750 E 63323-750-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/10ML (5MG/ML)
Approval Date:Jun 10, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/20ML (5MG/ML)
Approval Date:Jun 10, 2010TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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