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


    Fleye Aps
    Hedehusenehedehusene , DK 2640                 NOL-DO  112-0264010-1/1/1
    86H--QZ   947419459299/FRAMES
                        10-DEC-2007                        NOT LISTED

    Leo Pharma A/S
    Ballerup , DK DK-2750                          NOL-DO  112-0493246-4/1/1
    65JIB21   942425627498-PERLUTEX
                        13-DEC-2007                        UNAPPROVED