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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 AEK-8360973-1/1/1


Manufacturer FEI3008596260
Manufacturer NameN Sarojini  
Manufacturer Address line 1Cherai N Paravur  
Manufacturer Address line 2  
Manufacturer's CityEranakulam  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Arab Emirates  
Product Code61PCA26  
FDA Product DescriptionMETFORMIN (ANTI-DIABETIC)  
Refusal Date06-Jan-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AEK-8360973-1/1/1
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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