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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 212457

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NDA 212457 describes CLOFARABINE, which is a drug marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hospira, Meitheal, MSN, Mylan Labs Ltd, and Novast Labs, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the CLOFARABINE profile page.

The generic ingredient in CLOFARABINE is clofarabine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the clofarabine profile page.

Summary for 212457

Tradename:	CLOFARABINE
Applicant:	Eugia Pharma
Ingredient:	clofarabine
Patents:	0

Pharmacology for NDA: 212457

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 212457

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	212457	ANDA	Eugia US LLC	55150-326	55150-326-01	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-326-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	20MG/20ML (1MG/ML)
Approval Date:	Oct 3, 2022	TE:		RLD:	No

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