• 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 112-8430149-0/3/2


Manufacturer FEI3005224455
Manufacturer NameDenk Pharma  
Manufacturer Address line 1816575 Muenchen  
Manufacturer Address line 2  
Manufacturer's CityMunich  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code66SCA27  
FDA Product DescriptionNIFEDIPINE (VASODILATOR)  
Refusal Date22-Sep-2010  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 112-8430149-0/3/2
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.  
-
-