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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091358

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NDA 091358 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 091358

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

Pharmacology for NDA: 091358

Suppliers and Packaging for NDA: 091358

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 091358 ANDA Mylan Institutional LLC 67457-442 67457-442-20 1 VIAL in 1 CARTON (67457-442-20) > 20 mL in 1 VIAL
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 091358 ANDA Mylan Institutional LLC 67457-469 67457-469-10 1 VIAL in 1 CARTON (67457-469-10) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/10ML (5MG/ML)
Approval Date:Aug 7, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/20ML (5MG/ML)
Approval Date:Aug 7, 2012TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength200MG/40ML (5MG/ML)
Approval Date:Nov 14, 2017TE:APRLD:No


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