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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 112-3782277-2/1/1

Manufacturer FEI3006595385
Manufacturer NameCadila Healthcare Limited India (Zyfine)  
Manufacturer Address line 1Plots 254-255 B/H Zyfine Unit  
Manufacturer Address line 2Sarkhej-Bavla Rd, NH 8A  
Manufacturer's CityTal Sanand, Ahmedabad  
Manufacturer Province/StateGujarat  
Manufacturer Country/AreaIndia  
Product Code62OCC14  
Importer's Product Description857454739012/AMLODIPIN  
Refusal Date13-Dec-2006  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-3782277-2/1/1
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.