Refusal Actions by FDA as Recorded in OASIS for Bahrain

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


    Teva Pharmaceuticals USA, Inc.
    Sellersville, PA  18960-1512                   NOL-DO  112-1208126-2/1/1
    64LCJ28   858081628456  Fluocinonide .05%, & Demra-Smoothe/FS Fluocino
                        14-FEB-2008                        AGR RX