Refusal Actions by FDA as Recorded in OASIS for Argentina

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Roemmers Saicf Buenos Aires , AR NOL-DO 112-7397250-7/3/1 66VCY99 857148776583 DOROXINA 31-AUG-2007 UNAPPROVED