Last Updated: September 24, 2026

Details for New Drug Application (NDA): 091358


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NDA 091358 describes OXALIPLATIN, which is a drug marketed by Accord Hlthcare, Actavis, Actavis Totowa, Am Regent, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hetero Labs Ltd Vi, Hospira Inc, Hospira Worldwide, Ingenus Pharms Llc, Meitheal, Mylan Labs Ltd, Pharmobedient, Qilu Pharm Hainan, Sandoz, Shandong, Sun Pharm, and Teva Pharms, and is included in twenty-nine NDAs. It is available from sixteen suppliers. Additional details are available on the OXALIPLATIN profile page.

The generic ingredient in OXALIPLATIN is oxaliplatin. There is one drug master file entry for this compound. Sixteen 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
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;INTRAVENOUS 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;INTRAVENOUS 091358 ANDA Mylan Institutional LLC 67457-469 67457-469-10 1 VIAL in 1 CARTON (67457-469-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/10ML (5MG/ML)
Approval Date:Aug 7, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/20ML (5MG/ML)
Approval Date:Aug 7, 2012TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength200MG/40ML (5MG/ML)
Approval Date:Nov 14, 2017TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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