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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 63-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AEK-7033998-7/2/2 25-Apr-2005 63ECA13 3005056756 Summer S Yono Iraq
 
112-6461933-9/2/1 14-Apr-2005 63EPA19 3005047790 Global Napi Egypt
 
AEK-7033998-7/2/1 25-Apr-2005 63FCA06 3005056756 Summer S Yono Iraq
 
AEK-7033998-7/2/4 25-Apr-2005 63FCA99 3005056756 Summer S Yono Iraq
 
112-6384132-2/1/1 13-Apr-2005 63FDY99 3004055168 Les Laboratories Servier Industrie France
 
112-6462367-9/1/1 29-Apr-2005 63FQY99 3003575424 Astra Zeneca United Kingdom
 
395-0078922-5/2/1 13-Apr-2005 63HAS01 3004509778 Kalvik Laboratories(P) Ltd India
 
M41-0752777-0/1/4 09-Apr-2005 63RBY04 1000569505 Choice Laboratories India
 
M76-1873280-5/5/1 14-Apr-2005 63RCJ04 3000166001 Germiphene Corporation Canada
 
M76-1873280-5/6/1 14-Apr-2005 63RCJ04 3000166001 Germiphene Corporation Canada
 
112-6411542-9/1/1 14-Apr-2005 63SAL99 3000166001 Germiphene Corporation Canada
 
112-6411542-9/2/1 14-Apr-2005 63SAL99 3000166001 Germiphene Corporation Canada
 
AEK-6523865-7/1/1 14-Apr-2005 63XCY99 3005025702 Dafra Pharma Belgium
 
112-6626640-2/2/1 28-Apr-2005 63XDA99 3004931876 Glaxosmithkline Inc Panama
 
112-6491900-2/2/1 28-Apr-2005 63XDA99 3004464238 Dr. Reddy's Laboratories Limited India
 
112-6626640-2/1/1 28-Apr-2005 63XDJ99 3005071969 Scherin Plug El Salvador
 
112-6492084-4/1/1 28-Apr-2005 63XDY99 3004399994 Laboratorio Franco Colombiano Lafrancol S.A. Colombia
 
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