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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 114-0181883-3/1/1

Manufacturer FEI3002806821
Manufacturer NameMSD Organon BV  
Manufacturer Address line 1Kloosterstraat 6  
Manufacturer Address line 2  
Manufacturer's CityOss  
Manufacturer Province/StateNoord-brabant  
Manufacturer Country/AreaNetherlands  
Product Code65XCC99  
FDA Product DescriptionSPERMATICIDE N.E.C.  
Refusal Date25-Jan-2005  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 114-0181883-3/1/1
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.