Last Updated: May 10, 2026

Details for New Drug Application (NDA): 219765


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NDA 219765 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, 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 are twenty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
Summary for 219765
Tradename:OXALIPLATIN
Applicant:Shandong
Ingredient:oxaliplatin
Patents:0
Pharmacology for NDA: 219765
Suppliers and Packaging for NDA: 219765
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 219765 ANDA Shandong New Time Pharmaceutical Co., Ltd. 42677-336 42677-336-10 10 VIAL, SINGLE-DOSE in 1 CARTON (42677-336-10) / 10 mL in 1 VIAL, SINGLE-DOSE (42677-336-01)
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 219765 ANDA Shandong New Time Pharmaceutical Co., Ltd. 42677-337 42677-337-10 10 VIAL, SINGLE-DOSE in 1 CARTON (42677-337-10) / 20 mL in 1 VIAL, SINGLE-DOSE (42677-337-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/10ML (5MG/ML)
Approval Date:Jan 15, 2026TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/20ML (5MG/ML)
Approval Date:Jan 15, 2026TE:APRLD:No

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Preferred Citation:

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