Last Updated: September 24, 2026

Details for New Drug Application (NDA): 217348


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NDA 217348 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 217348
Tradename:OXALIPLATIN
Applicant:Meitheal
Ingredient:oxaliplatin
Patents:0
Pharmacology for NDA: 217348
Suppliers and Packaging for NDA: 217348
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 217348 ANDA Meitheal Pharmaceuticals Inc. 71288-171 71288-171-11 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-171-11) / 10 mL in 1 VIAL, SINGLE-DOSE
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 217348 ANDA Meitheal Pharmaceuticals Inc. 71288-171 71288-171-91 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-171-91) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/10ML (5MG/ML)
Approval Date:Jan 11, 2024TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/20ML (5MG/ML)
Approval Date:Jan 11, 2024TE:APRLD:No

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Preferred Citation:

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