Last Updated: May 3, 2026

Details for New Drug Application (NDA): 215547

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NDA 215547 describes CLADRIBINE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Pharmobedient, Apotex, and Hopewell Pharma, and is included in six NDAs. It is available from six 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. Seven suppliers are listed for this compound. Additional details are available on the cladribine profile page.

Summary for 215547

Tradename:	CLADRIBINE
Applicant:	Hopewell Pharma
Ingredient:	cladribine
Patents:	0

Pharmacology for NDA: 215547

Medical Subject Heading (MeSH) Categories for 215547

Antineoplastic Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 215547

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLADRIBINE	cladribine	TABLET;ORAL	215547	ANDA	Sandoz Inc.	0781-8201	0781-8201-37	9 TABLET in 1 CARTON (0781-8201-37)
CLADRIBINE	cladribine	TABLET;ORAL	215547	ANDA	Sandoz Inc.	0781-8201	0781-8201-51	5 TABLET in 1 CARTON (0781-8201-51)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 27, 2026	TE:	AB	RLD:	No

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