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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 112-7909502-9/1/1

Manufacturer FEI1000476214
Manufacturer NameMead Johnson De Mexico/Bristol Myers de Mexico S.A. de C.V.  
Manufacturer Address line 1Carretera Panamericana, Km 1573  
Manufacturer Address line 2C.P. 33000  
Manufacturer's CityCiudad Delicias  
Manufacturer Province/StateChihuahua  
Manufacturer Country/AreaMexico  
Product Code61XCP99  
FDA Product DescriptionANTI-HISTAMINIC N.E.C.  
Refusal Date26-Oct-2005  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7909502-9/1/1
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.