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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 H87-0104803-0/5/6

Manufacturer FEI3003450798
Manufacturer NameAventis Pharma, S.A. De C.V.  
Manufacturer Address line 1Calle 2a # 42 Zona Industrial Benito  
Manufacturer Address line 2  
Manufacturer's CityQueretaro, Qro.  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code56GBJ99  
FDA Product DescriptionANTIFUNGAL N.E.C.  
Refusal Date27-Nov-2001  
FDA DistrictSWI-DO  
Entry/doc/line/sfx H87-0104803-0/5/6
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.