Refusal Actions by FDA as Recorded in OASIS for Costa Rica

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


    Newport Pharmaceutical
    San Jose , CR                                  NOL-DO  112-3142105-1/1/1
    60RDA19   852182433667 Sibutramina
                        21-JUL-2008                        NO ENGLISH
                                                           UNAPPROVED