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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204368

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NDA 204368 describes OXALIPLATIN, which is a drug marketed by Accord Hlthcare, Actavis Llc, Actavis Totowa, Cipla Ltd, Eugia Pharma, 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, 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 204368
Tradename:OXALIPLATIN
Applicant:Qilu Pharm Co Ltd
Ingredient:oxaliplatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204368
Suppliers and Packaging for NDA: 204368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 204368 ANDA Apotex Corp. 60505-6132 N 60505-6132-6
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 204368 ANDA Apotex Corp. 60505-6132 N 60505-6132-7

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/10ML (5MG/ML)
Approval Date:Jun 7, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/20ML (5MG/ML)
Approval Date:Jun 7, 2016TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength200MG/40ML (5MG/ML)
Approval Date:Jun 7, 2016TE:APRLD:No

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