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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
112-5471558-8/1/1 05-Feb-2010 64AAK99 3008085262 Aztex Enterprises Ltd Canada
 
EG6-1782608-6/5/1/A 16-Feb-2010 64ABK99 3005074387 All Terrain Co United States
 
EG6-1782608-6/5/1/B 16-Feb-2010 64ABK99 3005074387 All Terrain Co United States
 
EG6-1782608-6/5/1/D 16-Feb-2010 64ABK99 3005074387 All Terrain Co United States
 
EG6-1782608-6/5/1/C 16-Feb-2010 64ABK99 3005074387 All Terrain Co United States
 
EG6-1782608-6/5/1/E 16-Feb-2010 64ABK99 3005074387 All Terrain Co United States
 
EG6-1782608-6/5/1/F 16-Feb-2010 64ABK99 3005074387 All Terrain Co United States
 
EG6-1782608-6/5/1/G 16-Feb-2010 64ABK99 3005074387 All Terrain Co United States
 
AK9-0033969-3/2/1 09-Feb-2010 64BAS37 3005289386 Zhejiang Langhua Pharmaceutical China
 
AEK-6908606-0/2/1 23-Feb-2010 64EDA02 3008166472 Aeci Philippines
 
XXX-0167540-5/1/1/A 09-Feb-2010 64LDO08 3005404124 GlaxoSmith Kline India
 
112-8222535-1/1/1 18-Feb-2010 64MCK07 1220970 EMD Serono, Inc. United States
 
112-8222535-1/1/2 18-Feb-2010 64MCK07 1220970 EMD Serono, Inc. United States
 
112-8222535-1/1/3 18-Feb-2010 64MCK13 1220970 EMD Serono, Inc. United States
 
112-8222535-1/1/4 18-Feb-2010 64MCK14 1220970 EMD Serono, Inc. United States
 
AEK-8061773-7/1/1 10-Feb-2010 64MCY04 3003941498 Wiler Pcca Ltd Canada
 
AEK-8007426-9/1/1 23-Feb-2010 64XAE11 3008109227 Tdi International India Ltd India
 
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