Refusal Actions by FDA as Recorded in OASIS for Austria

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


    Sandoz GmbH
    Kufstein , AT                                  ATL-DO  XXX-0154540-0/1/2
    56BDB05   Various Rx (no Rx Prescription)
                        29-JUL-2008                        UNAPPROVED

    Vidipha
    Unknown , VN                                   ATL-DO  XXX-0154540-0/1/3
    66VDY99   Various Rx (no Rx Prescription)
                        29-JUL-2008                        UNAPPROVED