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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 112-4442140-5/1/1

Manufacturer FEI3001224516
Manufacturer NameSankyo Pharma  
Manufacturer Address line 1Zielstattstrabe 9  
Manufacturer Address line 2  
Manufacturer's CityMunchen  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53AD02  
Importer's Product Description876743051720 HIRUDOID CREAM  
Refusal Date16-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4442140-5/1/1
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.