Refusal Actions by FDA as Recorded in OASIS for Denmark

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Pharma Nord
    Vojens , DK 6500                               NYK-DO  112-8613240-4/1/1
    66VDY99   860312720993 CIPRALEX 10 mg TABLETS
                        08-NOV-2007                        UNAPPROVED