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Serving 500+ biopharmaceutical companies globally:

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Generated: June 28, 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 Actavis Totowa, Fresenius Kabi Oncol, Sandoz Inc, Hospira Worldwide, Hospira Inc, Qilu Pharm Co Ltd, Sandoz, Sun Pharma Global, Fresenius Kabi Usa, Cipla Ltd, Gland Pharma Ltd, Mylan Labs Ltd, Teva Pharms, Jiangsu Hengrui Med, Accord Hlthcare, and Luitpold Pharms Inc, and is included in twenty-three NDAs. It is available from sixteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.

Summary for NDA: 078817

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 500+ biopharmaceutical companies globally:

Argus Health
Queensland Health
Cantor Fitzgerald
QuintilesIMS
McKesson
Colorcon
Johnson and Johnson
Mallinckrodt
Cipla
Dow

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