Refusal Actions by FDA as Recorded in OASIS for Netherlands

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Amstelfarma Bv Lelystad , NL NYK-DO AEK-9090796-1/1/1 60WIA16 MEBENDAZOLE 500 MG 12-FEB-2008 NOT LISTED UNAPPROVED Guilin South Rubber (Group) Corp. Guilin, Guangxi , CN 541001 NYK-DO F23-0990503-2/6/1 85H--IS CONDOMS 12-FEB-2008 REGISTERED HOLES