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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 076571

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NDA 076571 describes CLADRIBINE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, and Norvium Bioscience, and is included in four NDAs. It is available from three suppliers. Additional details are available on the CLADRIBINE profile page.

The generic ingredient in CLADRIBINE is cladribine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cladribine profile page.

Summary for 076571

Tradename:	CLADRIBINE
Applicant:	Fresenius Kabi Usa
Ingredient:	cladribine
Patents:	0

Pharmacology for NDA: 076571

Medical Subject Heading (MeSH) Categories for 076571

Antineoplastic Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 076571

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLADRIBINE	cladribine	INJECTABLE;INJECTION	076571	ANDA	Fresenius Kabi USA, LLC	63323-140	63323-140-10	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Apr 22, 2004	TE:	AP	RLD:	No

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