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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 202922

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NDA 202922 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 202922

Tradename:	OXALIPLATIN
Applicant:	Sun Pharm
Ingredient:	oxaliplatin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Apr 8, 2014	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	100MG/20ML (5MG/ML)
Approval Date:	Apr 8, 2014	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	200MG/40ML (5MG/ML)
Approval Date:	Feb 15, 2019	TE:		RLD:	No

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