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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 65-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
ES3-3007124-3/1/1 27-Dec-2007 65AAR99 3005095227 Hongze Chenguang Fine Cchemical Co. Ltd. China
 
112-0224654-5/1/1 06-Dec-2007 65BCR01 3005442082 Zambon Italia Srl Italy
 
112-0510785-0/1/1 18-Dec-2007 65CCK07 1000327754 Sigma Tau Italy
 
112-0496449-1/1/1 14-Dec-2007 65CDK07 2245635 Sigma-Tau Pharmaceuticals, Inc. United States
 
112-0246256-3/1/1 10-Dec-2007 65JDB24 3004672766 Glenmark Generics Limited India
 
XXX-0217983-7/1/1 03-Dec-2007 65JDB27 2211100 Janssen Pharmaceuticals, Inc. United States
 
112-0493246-4/1/1 13-Dec-2007 65JIB21 3002807496 Leo Pharma A/S Denmark
 
112-0492190-5/1/1 13-Dec-2007 65QIB22 1000596246 Whitehall Robins Inc Canada
 
AEK-9053293-4/1/1 04-Dec-2007 65VCA13 3006524375 V.N. Surendran India
 
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