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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal AEK-7150773-1/1/2

Manufacturer FEI3006023402
Manufacturer NameMardstone Hospital  
Manufacturer Address line 1Heritage Lane  
Manufacturer Address line 2  
Manufacturer's CityMaristone Kent  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code62OCA22  
Importer's Product DescriptionCARVEDILOL  
Refusal Date18-Dec-2006  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AEK-7150773-1/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.