Refusal Actions by FDA as Recorded in OASIS for Egypt
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Aventis Pharma
Alexandria , EG NOL-DO 112-0116657-9/1/1
64MCB01 954558815958/CLOMID
06-MAR-2008 UNAPPROVED
Amoum Co
Cairo , EG NOL-DO 112-1777626-2/1/1
62CCP99 EFEXOR (VENLAFAXINE HCL)
18-MAR-2008 UNAPPROVED
Glaxo Co
Cairo , EG NOL-DO 112-1777626-2/1/3
62CCP99 CONCOR (BISOPROLOL)
18-MAR-2008 UNAPPROVED
Waith Co
Cairo , EG NOL-DO 112-1777626-2/1/2
62CCP99 SEROXAT PAROXETINE
18-MAR-2008 UNAPPROVED
Pharma Co
Cairo , EG NOL-DO 112-1777626-2/2/1
54AYY99 963999000010 VITAMIN SAMPLES
21-MAR-2008 NUTRIT LBL