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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 60-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-7279577-7/3/1 26-Aug-2009 60CAR57 3007518875 Novartis Consumer Health Schweiz Belgium
 
112-6893280-6/1/1 25-Aug-2009 60CBQ53 3004437293 Novartis Switzerland
 
112-6028526-0/1/1 03-Aug-2009 60CDP55 3004561553 Sun Pharmaceutical Industries, LTD India
 
523-0860852-1/1/1 06-Aug-2009 60EAS01 3004870616 Shanghai Record Pharmaceuticals Co., Ltd. China
 
112-8619792-9/2/1 13-Aug-2009 60KDA15 3007749105 Nanjing Organon Pharmaceutical C China
 
BQL-0019396-9/6/1 04-Aug-2009 60L01 3003991563 Moscow Pharmaceutical Factory Russia
 
112-8251136-2/2/1 12-Aug-2009 60LCE82 3007684621 Winthrop Pharmaceuticals Phils Philippines
 
112-8251136-2/2/2 12-Aug-2009 60LCE83 3003621956 United Laboratories Inc Philippines
 
112-7336660-2/1/1 26-Aug-2009 60LDA05 3004537450 Wyeth Consumer Hea Canada
 
BHC-5003124-2/11/2 21-Aug-2009 60LDA14 3003092769 Teva Pharmaceuticals USA United States
 
112-6469204-0/1/4 18-Aug-2009 60LDA17 3005206252 Laboratorios Grossmann Mexico
 
112-7280064-3/1/2 26-Aug-2009 60LDL01 3003712444 Glaxosmithkline Exp United Kingdom
 
112-8251136-2/3/1 12-Aug-2009 60PCE03 3006554302 Zuellig Pharma Philippines
 
BHC-5003124-2/32/1 21-Aug-2009 60QDL07 1420913 Morton Grove Pharmaceuticals, Inc. United States
 
112-4739630-5/1/1 19-Aug-2009 60SCB27 3007158581 Aci Ltd. Bangladesh
 
BHC-5003124-2/29/1 21-Aug-2009 60SDA22 3003359727 Par Pharmaceuticals United States
 
BHC-5003124-2/34/2 21-Aug-2009 60SDA23 3010368539 Url Pharma United States
 
BHC-5003124-2/33/1 21-Aug-2009 60SDL06 1000416547 Pfizer Inc. United States
 
112-6714743-0/1/1 21-Aug-2009 60WIS16 3005367984 Iffect Chemphar(Sh China
 
112-6766105-9/1/1 21-Aug-2009 60XCB02 3002906944 Apotex Inc. Canada
 
BHC-5003124-2/4/1 21-Aug-2009 60XDA20 3006234685 Mylan Lab Inc United States
 
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