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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202922

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NDA 202922 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 nineteen 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-two suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.

Summary for 202922

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

Pharmacology for NDA: 202922

Suppliers and Packaging for NDA: 202922

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 202922 ANDA Sun Pharma Global FZE 47335-046 47335-046-40 1 VIAL, SINGLE-USE in 1 CARTON (47335-046-40) > 10 mL in 1 VIAL, SINGLE-USE
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 202922 ANDA Sun Pharma Global FZE 47335-047 47335-047-40 1 VIAL, SINGLE-USE in 1 CARTON (47335-047-40) > 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:Apr 8, 2014TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/20ML (5MG/ML)
Approval Date:Apr 8, 2014TE:APRLD:No


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