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Generated: October 21, 2018

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Details for New Drug Application (NDA): 076571

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NDA 076571 describes CLADRIBINE, which is a drug marketed by Fresenius Kabi Usa, Mylan Labs Ltd, and West-ward Pharms Int, and is included in three NDAs. It is available from two 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. Two suppliers are listed for this compound. Additional details are available on the cladribine profile page.
Summary for 076571
Tradename:CLADRIBINE
Applicant:Fresenius Kabi Usa
Ingredient:cladribine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076571
Medical Subject Heading (MeSH) Categories for 076571
Suppliers and Packaging for NDA: 076571
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLADRIBINE cladribine INJECTABLE;INJECTION 076571 ANDA Fresenius Kabi USA, LLC 63323-140 63323-140-10 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-140-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Apr 22, 2004TE:APRLD:No

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