• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail

Refusal Details as Recorded in OASIS by FDA

for Refusal 112-8426719-2/1/1

Manufacturer FEI3004530491
Manufacturer NameNeopharm Ltd  
Manufacturer Address line 1P.o. Box 3506  
Manufacturer Address line 2  
Manufacturer's CityPetach Tikva  
Manufacturer Province/State  
Manufacturer Country/AreaIsrael  
Product Code61JCY01  
Refusal Date24-Oct-2005  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8426719-2/1/1
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.