Refusal Actions by FDA as Recorded in OASIS for Netherlands

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


    Solvay Pharmaceuticals
    Weesp , NL 1380                                NOL-DO  112-2055027-4/2/1
    66SCA03   942532941440  BETASERC  8MG
                        02-APR-2008                        UNAPPROVED

    Crest International bv
    Weert NL-LI, NL 6003DE                         NOL-DO  112-1883975-4/1/1
    33YFY99   909287271074 LOLLIPOPS
                        04-APR-2008                        COLOR LBLG
                                                           YELLOW #5

    Solvay Pharmaceuticals
    Weesp , NL NL-1381 DA                          NOL-DO  112-2039508-4/2/1
    66YCB99   920133594134 BETASERC 80MG
                        09-APR-2008                        UNAPPROVED

    Enrico  It.Spec.
    Amsterdam , NL 1046AB                          CHI-DO  109-0903505-6/15/1
    37KCE99   AEGEAN PASTE
                        15-APR-2008                        NUTRIT LBL