Refusal Actions by FDA as Recorded in OASIS for Australia

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


    Foreign Trade Zone#202-A3m Pharmaceuticals
    Northridge, CA  91328                          LOS-DO  336-8064699-2/3/1
    60LBA08   BENZYDAMINE HCL (ANALGESIC);HUMAN N/RX COMB INGR;PROMPT RELE
                        05-JUN-2008                        NOT LISTED
                                                           UNAPPROVED

    Tiger Chemical Company
    North Melbourne , AU                           LOS-DO  DO7-1108576-4/1/1
    65JSW31   ALTRENOGEST FOR RESEARCH ONLY
                        13-JUN-2008                        UNAPPROVED

    Punja & Sons Ltd
    Lautoka , FJ                                   SAN-DO  K80-0949664-8/7/2
    09CCT16   RED COW MILK POWDER
                        25-JUN-2008                        LIST INGRE
                                                           LACKS N/C
                                                           NUTRIT LBL