Refusal Actions by FDA as Recorded in OASIS for Hungary

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


    Novartis Hungaria Klt
    Budapest , HU 1027                             NOL-DO  112-0527314-0/1/1B
    62UDR99   862026994708 Neo Citran
                        27-MAY-2008                        UNAPPROVED