Refusal Actions by FDA as Recorded in OASIS for Greece

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


    Speedex Sa
    Athens , GR 11855                              NYK-DO  UPS-1755548-1/1/1
    61PDB55   MEDICATION FOR DIABETES MELLITUS(GLUCOPHAGE 850MG 30 TABLETS
                        21-AUG-2008                        UNAPPROVED