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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
M21-0749569-1/1/1 05-Feb-2014 61EAA08 3002093078 Vasudha Pharma Chem Limited India
 
UPS-3830603-3/2/1 10-Feb-2014 61JCY08 3008354462 Teva Pharmaceuticals Netherlands
 
101-3694348-7/1/1 18-Feb-2014 61KCS34 3008554428 Synkem France
 
UPS-3956652-8/1/1 11-Feb-2014 61LCP29 3003195501 Sanofi-Aventis Deutschland GmbH Germany
 
AEK-4535399-8/1/1 24-Feb-2014 61NCY23 3010618187 V Nanda Kumar India
 
M21-0749584-0/1/1 05-Feb-2014 61PAB11 3010630783 Merix Laboratories Private Limited India
 
XXX-0220688-7/1/2 28-Feb-2014 61PDB26 3005641485 Silanes Laboratorios S.A. de C.V. Mexico
 
D52-5867413-9/1/1 07-Feb-2014 61TCH99 3006614085 Eisai Inc United States
 
UPS-4224922-9/2/1 21-Feb-2014 61TDB26 3004688211 GlaxoSmithKline United States
 
799-2840207-6/1/1 28-Feb-2014 61WCZ18 3008498699 Hangzhou Dayangchem Co Ltd China
 
UPS-3985868-5/1/1/A 18-Feb-2014 61XCY14 3010610358 Melle Binsalam Thailand
 
AEK-4544049-8/3/1 25-Feb-2014 61XCY99 3005440275 Rottapharm Spa Italy
 
U59-2014786-0/1/1 14-Feb-2014 61XDR50 3002807919 Prime European Therapeuticals S.p.A., abbr Euticals S.p.A. Italy
 
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