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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 112-8442615-2/1/1


Manufacturer FEI3005328139
Manufacturer NameGlaxo Smith Kline  
Manufacturer Address line 1Buyudere Cad. No 173, 1 Leven  
Manufacturer Address line 2  
Manufacturer's CityIstanbul  
Manufacturer Province/State  
Manufacturer Country/AreaTurkey  
Product Code61PDY61  
Importer's Product Description849581653743 AVANDIA  
Refusal Date24-Oct-2005  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8442615-2/1/1
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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