Last Updated: September 24, 2026

Details for New Drug Application (NDA): 207325


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NDA 207325 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 207325
Tradename:OXALIPLATIN
Applicant:Gland
Ingredient:oxaliplatin
Patents:0
Pharmacology for NDA: 207325
Suppliers and Packaging for NDA: 207325
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 207325 ANDA Gland Pharma Limited 68083-176 68083-176-01 1 VIAL, SINGLE-USE in 1 CARTON (68083-176-01) / 10 mL in 1 VIAL, SINGLE-USE
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 207325 ANDA Gland Pharma Limited 68083-177 68083-177-01 1 VIAL, SINGLE-USE in 1 CARTON (68083-177-01) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/10ML (5MG/ML)
Approval Date:Feb 10, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/20ML (5MG/ML)
Approval Date:Feb 10, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength200MG/40ML (5MG/ML)
Approval Date:Oct 18, 2017TE:RLD:No

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Preferred Citation:

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