Refusal Actions by FDA as Recorded in OASIS for Romania

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


    Andibiotice Sa
    Iasi , RO 707040                               NOL-DO  112-2967639-3/1/1
    56BCF55   864286386394 OXACILINA 500MG
                        24-JUN-2008                        UNAPPROVED