Refusal Actions by FDA as Recorded in OASIS for Venezuela

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


    Lab Pharma Venezuela
    Caracas , VE 1070                              NOL-DO  112-0138411-5/1/1
    62OCB37   943887422316 APROVEL
                        06-MAR-2008                        UNAPPROVED

    Sanofi Synthelado
    Piso , VE 22710                                NOL-DO  112-0138411-5/1/2
    62OCB24   943887422316 CORAZEM
                        06-MAR-2008                        UNAPPROVED

    Biotech Laboratories
    Caracas , VE                                   NOL-DO  112-7788023-2/1/1
    54FBA99   791420318669  MADECASSOL 30MG
                        07-MAR-2008                        NO ENGLISH

    Mrw
    Caracas , VE                                   NOL-DO  112-0109164-5/1/1
    66NAA02   929420339108 ZYPREXA
                        10-MAR-2008                        UNAPPROVED

    FACTORIA DEL LAGO C.A.
    MARACAIBO VE-V, VE N/A                         FLA-DO  HQ7-0040618-9/2/1
    16JGC01   CLAW AND CRAB MEAT FRESH
                        10-MAR-2008                        FALSE

    Pfizer Laboratories
    Caracas , VE                                   NOL-DO  112-1722540-1/1/1
    65KCO08   861819285980 KALATAN
                        17-MAR-2008                        UNAPPROVED

    Abbott Laboratories C.A.
    Caracas , VE 1412                              NOL-DO  112-1721817-4/1/1
    66VIP99   929420369902 FERROFOLIC 525MG
                        20-MAR-2008                        UNAPPROVED

    Sandoz Venezuela S.A.
    Caracas , VE 1050                              NOL-DO  112-1721817-4/1/2
    66VIP99   929420369902 LORAZEPAM 1MG
                        20-MAR-2008                        UNAPPROVED