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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 UPS-8835996-1/1/1

Manufacturer FEI3006989916
Manufacturer NameMcneil Consumer Healthcare  
Manufacturer Address line 188 Mc Nabb St  
Manufacturer Address line 2  
Manufacturer's CityMarkham  
Manufacturer Province/StateON  
Manufacturer Country/AreaCanada  
Product Code66BAY44  
Importer's Product DescriptionNICORETTE GUM  
Refusal Date08-Sep-2010  
FDA DistrictMIN-DO  
Entry/doc/line/sfx UPS-8835996-1/1/1
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.