Refusal Actions by FDA as Recorded in OASIS for South Africa

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


    Adcock Ingram Limited
    Bryanston , ZA 2021                            NOL-DO  112-2204460-7/1/1
    66MCY03   852395298480/ALPRAZOLAM
                        21-APR-2008                        UNAPPROVED