Details for New Drug Application (NDA): 217348

NDA 217348 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 217348

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

Pharmacology for NDA: 217348

Suppliers and Packaging for NDA: 217348

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	217348	ANDA	Meitheal Pharmaceuticals Inc.	71288-171	71288-171-11	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-171-11) / 10 mL in 1 VIAL, SINGLE-DOSE
OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	217348	ANDA	Meitheal Pharmaceuticals Inc.	71288-171	71288-171-91	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-171-91) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Jan 11, 2024	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	100MG/20ML (5MG/ML)
Approval Date:	Jan 11, 2024	TE:	AP	RLD:	No

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