Details for New Drug Application (NDA): 207385

NDA 207385 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 207385

Tradename:	OXALIPLATIN
Applicant:	Gland
Ingredient:	oxaliplatin
Patents:	0

Pharmacology for NDA: 207385

Suppliers and Packaging for NDA: 207385

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	207385	ANDA	Gland Pharma Limited	68083-170	68083-170-01	10 mL in 1 VIAL (68083-170-01)
OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	207385	ANDA	Gland Pharma Limited	68083-171	68083-171-01	20 mL in 1 VIAL (68083-171-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	May 23, 2017	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	May 23, 2017	TE:	AP	RLD:	No

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