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Last Updated: December 7, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200510

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NDA 200510 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 200510
Applicant:Mylan Labs Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 200510
Medical Subject Heading (MeSH) Categories for 200510
Suppliers and Packaging for NDA: 200510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLADRIBINE cladribine INJECTABLE;INJECTION 200510 ANDA Mylan Institutional LLC 67457-450 67457-450-10 1 VIAL in 1 CARTON (67457-450-10) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Oct 6, 2011TE:APRLD:No

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