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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 213461

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NDA 213461 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 213461

Tradename:	CLOFARABINE
Applicant:	Meitheal
Ingredient:	clofarabine
Patents:	0

Pharmacology for NDA: 213461

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 213461

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	213461	ANDA	Meitheal Pharmaceuticals Inc.	71288-128	71288-128-20	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-128-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	20MG/20ML (1MG/ML)
Approval Date:	Oct 23, 2020	TE:	AP	RLD:	No

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