Refusal Actions by FDA as Recorded in OASIS for Panama

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


    Glaxosmithkline Export Panama Sa
    Panama , PA                                    ATL-DO  XXX-0151423-2/1/3
    66VDY99   Padrax en Polvo Tabs
                        13-MAR-2008                        PERSONALRX

    GlaxoSmithKline Panama S.A.
    Panama , PA 5678                               ATL-DO  XXX-0151441-4/1/4
    60LDA05   Mejoral (acetylsalicylic acid) tablets
                        13-MAR-2008                        NOT LISTED
                                                           NO ENGLISH

    GlaxoSmithKline Panama S.A.
    Panama , PA 5678                               ATL-DO  XXX-0151441-4/1/5
    60LDA05   Cardio Mejoral (acetylsalicylic acid) tablets 100mg
                        13-MAR-2008                        NOT LISTED
                                                           NO ENGLISH

    Glaxo Smithkline Panama Sa
    Panama , PA                                    ATL-DO  XXX-0151788-8/1/1M
    91D--IF   mejoral alleviates pain lowers fever
                        13-MAR-2008                        DIRECTIONS

    Merck Mexico, S.A.
    Naucalpan De Juarez MEX, MX 53370              ATL-DO  XXX-0151788-8/1/1N
    91D--IF   Glibenclamide is used in the treatment of non-insulin depend
                        13-MAR-2008                        DIRECTIONS

    Unknown
    Unknown , PA                                   NOL-DO  112-2329495-2/1/1
    64UIB08   858054976316 AVODART
                        31-MAR-2008                        UNAPPROVED

    Unknown
    Unknown , PA                                   NOL-DO  112-2329180-0/1/1
    64UIB08   858054976280 AVODART
                        31-MAR-2008                        UNAPPROVED