Refusal Actions by FDA as Recorded in OASIS for Saudi Arabia

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


    Abdallah Omar Ahmed
    Jeddah , SA                                    SEA-DO  429-0772409-2/1/1A
    64LCO67   Dermovate cream
                        18-AUG-2008                        UNAPPROVED

    Abdallah Omar Ahmed
    Jeddah , SA                                    SEA-DO  429-0772409-2/1/1B
    64LCO67   Dermovate ointment
                        18-AUG-2008                        UNAPPROVED

    Abdallah Omar Ahmed
    Jeddah , SA                                    SEA-DO  429-0772409-2/1/1C
    64LCO67   Betnovate cream
                        18-AUG-2008                        UNAPPROVED

    Ayman Said Bdallah
    Jeddah , SA                                    SEA-DO  429-0772421-7/7/1A
    64LCO67   Esapharma MOVATE Cream
                        18-AUG-2008                        UNAPPROVED

    Ayman Said Bdallah
    Jeddah , SA                                    SEA-DO  429-0772421-7/7/1B
    64LCO67   LEMONVATE CREAM
                        18-AUG-2008                        UNAPPROVED