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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
112-2536798-9/1/1 21-May-2008 63BBQ25 3002807086 GlaxoSmithKline Inc. Canada
 
XXX-0154083-1/1/24 28-May-2008 63BCL02 3004548237 Donovan Werke G.S.A International Guatemala
 
521-0059480-4/1/1 01-May-2008 63BCS99 3003263118 Pan Drugs Ltd. India
 
AEK-9102088-9/1/1 30-May-2008 63BDZ25 3002807777 IVAX (Teva) Pharmaceuticals Ireland Ireland
 
WMV-0373183-4/1/1 06-May-2008 63BIY25 3005389225 Vectura Group Plc United Kingdom
 
112-2538145-1/1/1 30-May-2008 63FIS99 3006423204 Shanghai F-Z International Co China
 
DO7-8718461-6/1/1 19-May-2008 63HCS10 3002807014 Fresenius Kabi Austria Gmbh Austria
 
D03-0162236-7/24/1/D 16-May-2008 63RAJ99 3006076426 Xlear, Incorporated United States
 
D03-0162236-7/24/1/E 16-May-2008 63RAJ99 3006076426 Xlear, Incorporated United States
 
408-1161292-5/11/1/C 05-May-2008 63VAL99 1000131550 Parfums Christian Dior France
 
408-1161292-5/11/1/A 05-May-2008 63VAL99 1000131550 Parfums Christian Dior France
 
408-1161292-5/11/1/B 05-May-2008 63VAL99 1000131550 Parfums Christian Dior France
 
112-2841882-1/1/1 23-May-2008 63VBY02 3006894180 Rdl Pharmaceutical Philippines
 
112-2172237-7/1/4 14-May-2008 63XDY99 3006758904 Solvang Pharma Inc Philippines
 
112-2172237-7/1/1 14-May-2008 63XDY99 3006758903 Procter And Gamble Philippines
 
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