Refusal Actions by FDA as Recorded in OASIS for Portugal

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


    Bayer Portugal Sa
    Carnaxide , PT                                 NOL-DO  112-3465107-6/1/1
    60LAA05   791922999996  ASA (Acetylsalicylic Acid)
                        21-JUL-2008                        UNAPPROVED