Refusal Actions by FDA as Recorded in OASIS for Israel

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Medibrands Ltd Yokeam Elit , IL NYK-DO G32-0130013-1/1/1 60QCY52 VIRACTIN GEL 7.1 G 06-AUG-2008 NOT LISTED UNAPPROVED Medibrands Ltd Yokeam Elit , IL NYK-DO G32-0130013-1/2/1 60QCY52 VIRACTIN GEL 7.1G 06-AUG-2008 NOT LISTED UNAPPROVED Top Respect Industrial (Shenzhen) Limited Shenzhen , CN LOS-DO BLW-0524935-0/5/1B 79O--BS ALFISPA MINI SYSTEM LIGHT MACHINE (Multi Function Space Caps 07-AUG-2008 NOT LISTED REGISTERED Syneron Medical Ltd. Yokneam, Illit , IL 20692 FLA-DO 336-8704221-1/2/1 79N--UV MASSAGER, VACCUUM, LIGHT INDUCED HEATING;; 12-AUG-2008 REGISTERED Syneron Medical Ltd. Yokneam, Illit , IL 20692 FLA-DO 336-8704221-1/2/2 79N--UV MASSAGER, VACCUUM, LIGHT INDUCED HEATING;; 12-AUG-2008 REGISTERED Syneron Medical Ltd. Yokneam, Illit , IL 20692 FLA-DO 336-8704221-1/5/1 79G--EX LASER INSTRUMENT, SURGICAL, POWERED;; 12-AUG-2008 REGISTERED A Meshi Cosmetics Industries Ltd Rishon Letzion , IL NYK-DO N77-0158931-9/1/17 66VDJ99 Super Acne Lotion 13-AUG-2008 NOT LISTED DIRECTIONS Baron International Trading Inc Kiryat Ono , IL NYK-DO F23-0996873-3/9/1 76E--FW TOOTH BRUSH 20-AUG-2008 NOT LISTED REGISTERED Yes Pharma Ltd Bet Shemesh , IL 99100 NOL-DO 112-1620342-5/1/1 63BDZ25 862019115379 FLUTICASONE PROPIONATE 22-AUG-2008 NOT LISTED UNAPPROVED Taro Pharmaceuticals Haifa , IL 26110 NYK-DO M76-8510336-9/3/1 64TCJ08 TACROLIMUS 0.1% TOPICAL OINTMT, PLACEBO LAB ANALYSIS ONLY, 22-AUG-2008 UNAPPROVED Taro Pharmaceuticals Haifa , IL 26110 NYK-DO M76-8510336-9/2/1 64TCJ08 TACROLIMUS 0.1% TOPICAL OINTMENT; LAB ANALYSIS ONLY, NOT FO 22-AUG-2008 UNAPPROVED