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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 112-8366784-8/1/1


Manufacturer FEI3004537221
Manufacturer NameBayer Americas  
Manufacturer Address line 1N 57-52  
Manufacturer Address line 2  
Manufacturer's CityBogota  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code61WCY03  
Importer's Product Description852846546969 BATRAFEN  
Refusal Date25-Oct-2005  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8366784-8/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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