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


    Synergy International
    Sharjah , AE                                   NOL-DO  112-7043350-3/1/1
    65PDB02   Sildenafil Citrate 100mg
                        01-APR-2008                        UNAPPROVED

    Synergy International
    Sharjah , AE                                   NOL-DO  112-7043658-9/1/1
    66SCA51   Tadalafil
                        01-APR-2008                        UNAPPROVED

    Synergy International
    Sharjah , AE                                   NOL-DO  112-7044426-0/1/1
    65PDB02   Sildenafil Citrate 100mg
                        01-APR-2008                        UNAPPROVED

    Synergy International
    Sharjah , AE                                   NOL-DO  112-7044189-4/1/1
    65PDB02   Sildenafil Citrate 50mg
                        01-APR-2008                        UNAPPROVED

    Mohd
    Sharjah , AE                                   NYK-DO  AEK-9099553-7/1/1
    40CHT25   BABY INFANT FORMULA
                        16-APR-2008                        STD QUALIT