Refusal Actions by FDA as Recorded in OASIS for United Arab Emirates

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


    Gulf Pharmaceutical Co
    Ras Al Khaimah , AE                            NOL-DO  112-0327401-7/1/2
    64BCA25   857269140440/HYDROCHLOROTHIAZE
                        11-DEC-2007                        UNAPPROVED

    Gulf Pharmaceutical Co
    Ras Al Khaimah , AE                            NOL-DO  112-0327401-7/1/1
    62OCB22   857269140440/CARDILOL
                        11-DEC-2007                        UNAPPROVED

    Al Naseem Pharmacy
    Al Ghusals , AE                                NOL-DO  112-0389361-8/1/1
    62OCB41   861718631798/COZAAR .50MG
                        11-DEC-2007                        UNAPPROVED

    Al Naseem Pharmacy
    Al Ghusals , AE                                NOL-DO  112-0389361-8/1/2
    64BCB24   861718631798/LASIX .40MG
                        11-DEC-2007                        UNAPPROVED

    Al Hokamaa Pharmacy
    Al Ghusias , AE                                NOL-DO  112-0389361-8/1/3
    66SCB40   861718631798/PHYSIOTENS .2MG
                        11-DEC-2007                        UNAPPROVED

    Empost
    Dubai , AE                                     NOL-DO  112-0659204-3/2/1
    86H--QG   932346813561 GLASS SPECS
                        27-DEC-2007                        NOT LISTED