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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022160

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NDA 022160 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 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-three suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
Summary for 022160
Tradename:OXALIPLATIN
Applicant:Teva Pharms
Ingredient:oxaliplatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022160
Suppliers and Packaging for NDA: 022160
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 022160 NDA Teva Parenteral Medicines, Inc. 0703-3985 N 0703-3985-01
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 022160 NDA Teva Parenteral Medicines, Inc. 0703-3986 N 0703-3986-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/10ML (5MG/ML)
Approval Date:Aug 7, 2009TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/20ML (5MG/ML)
Approval Date:Aug 7, 2009TE:APRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Julphar
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Harvard Business School
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Baxter
QuintilesIMS

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