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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078803

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NDA 078803 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 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 078803
Applicant:Actavis Totowa
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 Actavis Pharma, Inc. 45963-611 N 45963-611-53
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 078803 ANDA Actavis Pharma, Inc. 45963-611 N 45963-611-59

Profile for product number 001

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

Profile 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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