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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
Queensland Health
Teva
Cerilliant
Fuji
Boehringer Ingelheim
UBS
Cipla

Generated: April 21, 2018

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 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 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:OXALIPLATIN
Applicant:Mylan Labs Ltd
Ingredient:oxaliplatin
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 N 67457-442-20
OXALIPLATIN oxaliplatin INJECTABLE;IV (INFUSION) 091358 ANDA Mylan Institutional LLC 67457-469 N 67457-469-10

Profile for product number 001

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

Profile for product number 002

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

Profile 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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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Federal Trade Commission
Cipla
Medtronic
Daiichi Sankyo
Mallinckrodt
Boehringer Ingelheim
QuintilesIMS
Dow

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