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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204368


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NDA 204368 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, Gland Pharma Ltd, Hengrui Pharma, Hospira Inc, Hospira Worldwide, Kindos, Mylan Labs Ltd, Novast Labs, Qilu Pharm Hainan, Sandoz, Sun Pharm, and Teva Pharms, and is included in twenty-seven NDAs. It is available from nineteen 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. Twenty suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
Summary for 204368
Tradename:OXALIPLATIN
Applicant:Qilu Pharm Hainan
Ingredient:oxaliplatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204368
Suppliers and Packaging for NDA: 204368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 204368 ANDA Apotex Corp. 60505-6132 60505-6132-6 1 VIAL in 1 CARTON (60505-6132-6) / 10 mL in 1 VIAL
OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 204368 ANDA Apotex Corp. 60505-6132 60505-6132-7 1 VIAL in 1 CARTON (60505-6132-7) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/10ML (5MG/ML)
Approval Date:Jun 7, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/20ML (5MG/ML)
Approval Date:Jun 7, 2016TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength200MG/40ML (5MG/ML)
Approval Date:Jun 7, 2016TE:RLD:No

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