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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 112-4444654-8/3/1

Manufacturer FEI3004190915
Manufacturer NameToptech Antitles  
Manufacturer Address line 1Mauritslaan 15  
Manufacturer Address line 2  
Manufacturer's CityCuracao  
Manufacturer Province/State  
Manufacturer Country/AreaNetherlands Antilles  
Product Code61TCL99  
FDA Product DescriptionANTI-EMETIC/NAUSEANT N.E.C.  
Refusal Date18-Nov-2004  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4444654-8/3/1
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.