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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
US Army
Daiichi Sankyo
US Department of Justice
Cerilliant
Farmers Insurance
Merck
QuintilesIMS
UBS

Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078803

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NDA 078803 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 eighteen 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-one suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.

Summary for NDA: 078803

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

Pharmacology for NDA: 078803

Suppliers and Packaging for NDA: 078803

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 078803 ANDA Sagent Pharmaceuticals 25021-211 25021-211-20 1 VIAL in 1 CARTON (25021-211-20) > 10 mL in 1 VIAL
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 078803 ANDA Sagent Pharmaceuticals 25021-212 25021-212-50 1 VIAL in 1 CARTON (25021-212-50) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/VIAL
Approval Date:Aug 8, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/VIAL
Approval Date:Aug 8, 2012TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fuji
Mallinckrodt
Cantor Fitzgerald
Queensland Health
Baxter
McKesson
Medtronic
AstraZeneca
US Department of Justice
Deloitte

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