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Serving leading biopharmaceutical companies globally:

Covington
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Cantor Fitzgerald
Teva
Daiichi Sankyo
Harvard Business School

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078817

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NDA 078817 describes OXALIPLATIN, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Cipla Ltd, 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, Sanja Pharms Co, Sun Pharma Global, and Teva Pharms, and is included in twenty-four NDAs. It is available from nineteen 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-two suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.

Summary for 078817

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078817

Suppliers and Packaging for NDA: 078817

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 078817 ANDA Sandoz Inc 0781-3315 0781-3315-70 1 VIAL, SINGLE-USE in 1 CARTON (0781-3315-70) > 10 mL in 1 VIAL, SINGLE-USE
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 078817 ANDA Sandoz Inc 0781-3317 0781-3317-80 1 VIAL, SINGLE-USE in 1 CARTON (0781-3317-80) > 20 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/10ML (5MG/ML)
Approval Date:Jan 24, 2011TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/20ML (5MG/ML)
Approval Date:Jan 24, 2011TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Merck
Chubb
Accenture
Teva
Cantor Fitzgerald
Julphar
Federal Trade Commission
Queensland Health

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