You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for New Drug Application (NDA): 210856

✉ Email this page to a colleague

« Back to Dashboard

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.