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Last Updated: December 19, 2025

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, Meitheal, Mylan Labs Ltd, Novast Labs, Pharmobedient, Qilu Pharm Hainan, Sandoz, Sun Pharm, and Teva Pharms, and is included in twenty-eight NDAs. It is available from eighteen 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. Nineteen 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, 2025, www.DrugPatentWatch.com.
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