Refusal Actions by FDA as Recorded in OASIS for Sweden

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


    Aerosol Scandinavia Ab
    Vallentuna , SE 18632                          PHI-DO  KH5-0032984-3/1/1
    61SDQ99   HYDRO 40 FOAM, 75ML; NDC 23710-040-75
                        29-MAY-2008                        UNAPPROVED

    Aerosol Scandinavia Ab
    Vallentuna , SE 18632                          PHI-DO  KH5-0033130-2/1/1
    61SDQ99   HYDRO 40 FOAM, 75ML,40ML NDC:23710-040-75
                        29-MAY-2008                        UNAPPROVED