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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 110-5683616-0/1/1

Manufacturer FEI3004174480
Manufacturer NameLosan Pharma GmbH  
Manufacturer Address line 1Otto Hahn Strasse 13  
Manufacturer Address line 2  
Manufacturer's CityNeuenburg  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code55YP99  
Importer's Product DescriptionMUCINEX ( 50G & 100MG ) 72 NO ( ANALYTICAL FOR LABORATORY USE ONLY, N  
Refusal Date28-Sep-2006  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 110-5683616-0/1/1
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.