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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 61-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
UPS-1471843-3/2/1 29-Jul-2013 61BCA99 3004535463 Janssen Cilag Pty. Australia
 
UPS-1471843-3/1/1 29-Jul-2013 61BCA99 3002807336 Janssen Pharmaceutica, N.V. Belgium
 
112-3526028-4/1/1 29-Jul-2013 61FCC56 3010270137 Lasociete Arabe Tunisia
 
228-9443448-3/1/1 23-Jul-2013 61HBL05 3008355339 Arch Chemical United States
 
M21-0748320-0/1/1 26-Jul-2013 61HCA03 3006094247 Research Pharmaceutical Co Ltd China
 
EFR-0021513-0/1/3 30-Jul-2013 61KBJ06 3010148939 Comercializadora Quality Health Sa De Cv Mexico
 
XXX-0295566-5/1/1 12-Jul-2013 61LDY29 2222017 sanofi-aventis US, Inc. United States
 
112-3093005-5/1/1 30-Jul-2013 61MCF42 3003909356 UCB Pharma S.A. Belgium
 
AEK-0809308-6/1/1 30-Jul-2013 61NAB99 3010269113 Annpurna India
 
XXX-0177656-7/1/1 11-Jul-2013 61NCA32 3004086663 PSICOFARMA Mexico
 
112-3527460-8/1/1 29-Jul-2013 61NCB76 3004152717 Glaxosmithkline Brasil Ltda Brazil
 
112-3526028-4/1/3 29-Jul-2013 61PCC31 3010270139 Sanof Aventis Tunisia
 
XXX-0177399-4/3/1/F 11-Jul-2013 61XDC08 3009403094 PT Dankos Farma Indonesia
 
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