Refusal Actions by FDA as Recorded in OASIS for Ukraine

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/1/16 54FEL99 HERBAL COUGH DROPS 13-MAR-2008 LIST INGRE NO ENGLISH UNAPPROVED Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/1/17 54FBA99 HERBAL COUGH DROPS 13-MAR-2008 LIST INGRE NO ENGLISH UNAPPROVED Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/1/5 54FEL99 ECHNICEA TINCTURE 13-MAR-2008 LIST INGRE NO ENGLISH Excelvision Annonay , FR NYK-DO 940-0169725-2/2/4 66VAK99 Vita Iodurol (sterile eye drops) 13-MAR-2008 DIRECTIONS NO ENGLISH UNAPPROVED Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/2/5 54FEL99 HERBAL SUPPLEMENT 13-MAR-2008 NO ENGLISH UNAPPROVED Unknown Manufacturer unknown , DE NYK-DO 940-0169725-2/2/10 66VPA99 NervoHeel tablet 13-MAR-2008 NO ENGLISH UNAPPROVED Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/2/27 61RAA11 ACTIVATED CHARCOAL 13-MAR-2008 NO ENGLISH Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/14/1 66VAY99 SAGE LEAVES 13-MAR-2008 NO ENGLISH UNAPPROVED Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/27/1 66VAY99 FENNEL 13-MAR-2008 NO ENGLISH UNAPPROVED