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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021348

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NDA 021348 describes ZAVESCA, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the ZAVESCA profile page.

The generic ingredient in ZAVESCA is miglustat. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the miglustat profile page.
Summary for 021348
Applicant:Actelion Pharms Ltd
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details
Pharmacology for NDA: 021348
Suppliers and Packaging for NDA: 021348
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZAVESCA miglustat CAPSULE;ORAL 021348 NDA AUTHORIZED GENERIC CoTherix, Inc. 10148-201 N 10148-201-90
ZAVESCA miglustat CAPSULE;ORAL 021348 NDA Actelion Pharmaceuticals US, Inc. 66215-201 N 66215-201-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 31, 2003TE:ABRLD:Yes

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