Last Updated: September 24, 2026

Details for New Drug Application (NDA): 207385


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NDA 207385 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 207385
Tradename:OXALIPLATIN
Applicant:Gland
Ingredient:oxaliplatin
Patents:0
Pharmacology for NDA: 207385
Suppliers and Packaging for NDA: 207385
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 207385 ANDA Gland Pharma Limited 68083-170 68083-170-01 10 mL in 1 VIAL (68083-170-01)
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 207385 ANDA Gland Pharma Limited 68083-171 68083-171-01 20 mL in 1 VIAL (68083-171-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/VIAL
Approval Date:May 23, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/VIAL
Approval Date:May 23, 2017TE:APRLD:No

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Preferred Citation:

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