Refusal Actions by FDA as Recorded in OASIS for Ukraine

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


    A. Natterman & Cie Gmbh
    Cologne , DE 1234                              NYK-DO  940-0169725-2/1/4
    66VBF99   ESSENTIAL FORTE N30 CAPSULES
                        16-APR-2008                        NO ENGLISH
                                                           UNAPPROVED

    Pharm Invest Jv
    Chernovtsy , UA 48052                          NYK-DO  940-0169725-2/2/17
    65VAY99   MILK THISTLE LEAVES
                        16-APR-2008                        NO ENGLISH
                                                           UNAPPROVED

    Transo-Pharm Handels-GMBH
    Siek , DE 22962                                NOL-DO  112-0466927-2/1/1
    62IIS82   617212617194/IDARUBICIN
                        25-APR-2008                        UNAPPROVED