Details for New Drug Application (NDA): 203869

NDA 203869 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, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Qilu Pharm Hainan, Sandoz, Sun Pharm, and Teva Pharms, and is included in twenty-seven 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 203869

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

Pharmacology for NDA: 203869

Suppliers and Packaging for NDA: 203869

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	203869	ANDA	Sagent Pharmaceuticals	25021-233	25021-233-10	1 VIAL in 1 CARTON (25021-233-10) / 10 mL in 1 VIAL
OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	203869	ANDA	Sagent Pharmaceuticals	25021-233	25021-233-20	1 VIAL in 1 CARTON (25021-233-20) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Jun 18, 2014	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	100MG/20ML (5MG/ML)
Approval Date:	Jun 18, 2014	TE:	AP	RLD:	No

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