Details for New Drug Application (NDA): 205529

NDA 205529 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 205529

Tradename:	OXALIPLATIN
Applicant:	Eugia Pharma
Ingredient:	oxaliplatin
Patents:	0

Pharmacology for NDA: 205529

Suppliers and Packaging for NDA: 205529

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	205529	ANDA	Eugia US LLC	55150-331	55150-331-01	1 VIAL in 1 CARTON (55150-331-01) / 10 mL in 1 VIAL
OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	205529	ANDA	Eugia US LLC	55150-332	55150-332-01	1 VIAL in 1 CARTON (55150-332-01) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Sep 6, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	100MG/20ML (5MG/ML)
Approval Date:	Sep 6, 2017	TE:		RLD:	No

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