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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
Merck
Fuji
Cipla
Accenture
Queensland Health
Harvard Business School
US Army

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202922

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NDA 202922 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 202922
Tradename:OXALIPLATIN
Applicant:Sun Pharma Global
Ingredient:oxaliplatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202922
Suppliers and Packaging for NDA: 202922
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 202922 ANDA Sun Pharma Global FZE 47335-046 N 47335-046-40
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 202922 ANDA Sun Pharma Global FZE 47335-047 N 47335-047-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/10ML (5MG/ML)
Approval Date:Apr 8, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/20ML (5MG/ML)
Approval Date:Apr 8, 2014TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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Dow
Federal Trade Commission
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US Department of Justice
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