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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 217925


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NDA 217925 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 217925
Tradename:OXALIPLATIN
Applicant:Hetero Labs Ltd Vi
Ingredient:oxaliplatin
Patents:0
Pharmacology for NDA: 217925
Suppliers and Packaging for NDA: 217925
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 217925 ANDA Camber Pharmaceuticals, Inc. 31722-357 31722-357-10 1 VIAL, SINGLE-DOSE in 1 CARTON (31722-357-10) / 10 mL in 1 VIAL, SINGLE-DOSE
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 217925 ANDA Camber Pharmaceuticals, Inc. 31722-358 31722-358-20 1 VIAL, SINGLE-DOSE in 1 CARTON (31722-358-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/10ML (5MG/ML)
Approval Date:Jan 27, 2025TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/20ML (5MG/ML)
Approval Date:Jan 27, 2025TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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