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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 210856

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NDA 210856 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 210856

Tradename:	CLADRIBINE
Applicant:	Hisun Pharm Hangzhou
Ingredient:	cladribine
Patents:	0

Pharmacology for NDA: 210856

Medical Subject Heading (MeSH) Categories for 210856

Antineoplastic Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 210856

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLADRIBINE	cladribine	INJECTABLE;INJECTION	210856	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-010	42658-010-01	1 mL in 1 VIAL, SINGLE-DOSE (42658-010-01)
CLADRIBINE	cladribine	INJECTABLE;INJECTION	210856	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-010	42658-010-91	1 mL in 1 VIAL, SINGLE-DOSE (42658-010-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Nov 25, 2019	TE:	AP	RLD:	No

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