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Last Updated: December 4, 2021

DrugPatentWatch Database Preview

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 Pharms, Hisun Pharm Hangzhou, and Mylan Labs Ltd, and is included in four NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the cladribine profile page.
Summary for 210856
Applicant:Hisun Pharm Hangzhou
Formulation / Manufacturing:see details
Pharmacology for NDA: 210856
Medical Subject Heading (MeSH) Categories for 210856
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Nov 25, 2019TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

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