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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 218425

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NDA 218425 describes CLADRIBINE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Pharmobedient, and Apotex, and is included in five NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the cladribine profile page.

Summary for 218425

Tradename:	CLADRIBINE
Applicant:	Apotex
Ingredient:	cladribine
Patents:	0

Pharmacology for NDA: 218425

Medical Subject Heading (MeSH) Categories for 218425

Antineoplastic Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 218425

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLADRIBINE	cladribine	TABLET;ORAL	218425	ANDA	Apotex Corp.	60505-4791	60505-4791-1	10 TABLET in 1 CARTON (60505-4791-1)
CLADRIBINE	cladribine	TABLET;ORAL	218425	ANDA	Apotex Corp.	60505-4791	60505-4791-4	4 TABLET in 1 CARTON (60505-4791-4)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 24, 2025	TE:	AB	RLD:	No

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