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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 110-2128964-4/1/1


Manufacturer FEI3005331937
Manufacturer NameWexford Laboratories Pvt Ltd  
Manufacturer Address line 1# 13, 10th Main, Maruthi Industrestate  
Manufacturer Address line 2  
Manufacturer's CityBangalorebangalore  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code61FIY55  
FDA Product DescriptionCIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)  
Refusal Date11-Oct-2005  
FDA DistrictCIN-DO  
Entry/doc/line/sfx 110-2128964-4/1/1
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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