BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Federal Trade Commission
Express Scripts

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078810

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NDA 078810 describes OXALIPLATIN, which is a drug marketed by Accord Hlthcare, Actavis Llc, 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-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 078810
Applicant:Fresenius Kabi Oncol
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/VIAL
Approval Date:Aug 7, 2009TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/VIAL
Approval Date:Aug 7, 2009TE:APRLD:No

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