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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 64-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
EG6-1778389-9/1/1/A 02-Nov-2009 64AAL99 3002449500 Laboratoire Du Var Canada
 
EG6-1778389-9/1/1/B 02-Nov-2009 64AAL99 3002449500 Laboratoire Du Var Canada
 
EG6-1778389-9/1/1/C 02-Nov-2009 64AAL99 3002449500 Laboratoire Du Var Canada
 
112-5664151-8/1/2 02-Nov-2009 64BCA24 3003596612 Sanofi-Aventis U.S. LLC United States
 
112-3452939-7/1/1 02-Nov-2009 64BDA09 3002807496 Leo Pharma A/S Denmark
 
112-9379938-6/2/1 12-Nov-2009 64ECF03 3007894969 Solvay Pharma Ltd India
 
231-9609544-5/1/1 17-Nov-2009 64EIS99 3006167678 Bio- Technologies General (Israel) Israel
 
112-3075709-1/1/1 04-Nov-2009 64GCB07 3004442378 Schering Deutschland Gmbh Germany
 
112-8102949-9/1/1 06-Nov-2009 64HBL99 1000602756 Collins Limited Barbados
 
112-9102458-9/1/1 06-Nov-2009 64NCB06 3004724440 Schering-Plough S.A. Colombia
 
336-6449139-9/1/1 18-Nov-2009 64RCS99 3002807849 POLYPEPTIDE LABORATORIES A/S Denmark
 
112-9050498-7/1/1 06-Nov-2009 64UCA08 3006345108 Glaxosmithkline Consumer Health United States
 
112-8970148-7/1/1 06-Nov-2009 64UCX99 3006031727 Alexion Pharmaceuticals, Inc. United States
 
231-0223901-3/1/1 04-Nov-2009 64XAJ03 3002500733 Hermal Kurt Hermann Germany
 
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