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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 204029

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NDA 204029 describes CLOFARABINE, which is a drug marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys, Eugia Pharma, Gland, Hospira, Meitheal, MSN, Novast Labs, Pharmobedient, and Scinopharm Taiwan, and is included in twelve NDAs. It is available from nine 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. Nine suppliers are listed for this compound. Additional details are available on the clofarabine profile page.

Summary for 204029

Tradename:	CLOFARABINE
Applicant:	Abon Pharms Llc
Ingredient:	clofarabine
Patents:	0

Pharmacology for NDA: 204029

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 204029

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	204029	ANDA	Zydus Lifesciences Limited	49315-003	49315-003-06	1 VIAL, SINGLE-USE in 1 CARTON (49315-003-06) / 20 mL in 1 VIAL, SINGLE-USE
CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	204029	ANDA	Fresenius Kabi USA, LLC	63323-572	63323-572-70	1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	20MG/20ML (1MG/ML)
Approval Date:	May 9, 2017	TE:		RLD:	No

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