• 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 112-4444654-8/2/1


Manufacturer FEI3004190915
Manufacturer NameToptech Antitles  
Manufacturer Address line 1Mauritslaan 15  
Manufacturer Address line 2  
Manufacturer's CityCuracao  
Manufacturer Province/State  
Manufacturer Country/AreaNetherlands Antilles  
Product Code66MCK98  
Importer's Product Description792076403082 PROMETHAZINE HCI  
Refusal Date18-Nov-2004  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4444654-8/2/1
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.  
-
-