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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-7650100-6/2/1 28-Aug-2007 62BDB11 1000202144 Merck Sharp & Dohme Ltd United Kingdom
 
112-7758537-0/1/1 24-Aug-2007 62CCA41 3003768909 Kumar Organic Products Ltd. India
 
AEK-7182108-2/1/1 01-Aug-2007 62CCA65 3006263452 Sunil Sharma India
 
112-6756149-8/1/1 24-Aug-2007 62CIY41 3001904238 Perrigo Israel Pharmaceuticals Israel
 
M85-0049643-4/2/1/E 09-Aug-2007 62FBY20 3003155270 Chereles Audieulon Haiti
 
AEK-7191937-3/4/1 27-Aug-2007 62FCQ08 3006338504 Penka Dimitrova Stefanova Bulgaria
 
AEK-7191550-4/2/1 01-Aug-2007 62FCQ53 3006334542 Pn Viswanavathan India
 
112-7685259-9/1/1 24-Aug-2007 62FCY99 3005296202 Sandvik Venezuela
 
110-9227251-1/1/2 20-Aug-2007 62GCA18 3005557868 Todo Pak S De Rl De Cv Mexico
 
AEK-7192976-0/1/1 27-Aug-2007 62GCA18 3006345988 N L Opurum Nigeria
 
AEK-7192911-7/1/1 01-Aug-2007 62GCA99 3006345474 Uriach Otc Sl Spain
 
AEK-7192911-7/1/2 01-Aug-2007 62GCA99 3006345473 Laboratoria Estedio Estedi Sl Spain
 
AEK-7192911-7/1/3 01-Aug-2007 62GCA99 3003762427 Merck Sharp & Dohme De Espana Spain
 
AEK-7192911-7/1/5 01-Aug-2007 62GCB99 3003762427 Merck Sharp & Dohme De Espana Spain
 
AEK-7192911-7/2/1 01-Aug-2007 62GCB99 3003492806 Sanofi Winthrop Industrie France
 
112-7288476-0/1/1 28-Aug-2007 62GCY18 3004476143 Novartis Pharma Netherlands
 
110-9100997-1/1/2 15-Aug-2007 62ICK86 3004447666 Takeda Global Research & Development United States
 
110-9227251-1/1/1 20-Aug-2007 62KCA10 3005557868 Todo Pak S De Rl De Cv Mexico
 
W69-8007184-0/1/1 28-Aug-2007 62LLY34 3005350670 Jintan Chengxi Xinda Chemical Factory China
 
300-2036741-1/1/1 01-Aug-2007 62MBL01 3006319955 Amt Global Partners United States
 
277-0114687-3/15/1 08-Aug-2007 62MBL08 3006320255 BERTRAM CHEMICAL (1982) CO., LTD. Thailand
 
277-0114687-3/14/1/B 08-Aug-2007 62MBO01 3006080805 OLIC (Thailand) Limited Thailand
 
277-0114687-3/14/1/A 08-Aug-2007 62MBO01 3006080805 OLIC (Thailand) Limited Thailand
 
277-0114687-3/14/1/C 08-Aug-2007 62MBO08 3006320255 BERTRAM CHEMICAL (1982) CO., LTD. Thailand
 
112-7576472-0/1/1 08-Aug-2007 62NBA99 3004958693 Advitech Inc Canada
 
112-7746293-5/1/1 27-Aug-2007 62OAB05 3006410683 Monasan Ltd Germany
 
112-7650100-6/8/1 28-Aug-2007 62ODB14 3002114834 Pfizer Propriety Limited Australia
 
112-7650100-6/9/1 28-Aug-2007 62ODB14 3006400882 Hanmi Pharmacetical Co Ltd Korea, Republic Of (South)
 
112-7650100-6/3/1 28-Aug-2007 62ODB28 3004110321 Merck Sharp & Dohme (Australia) Pty Ltd Australia
 
112-7650100-6/3/2 28-Aug-2007 62ODB28 3004110321 Merck Sharp & Dohme (Australia) Pty Ltd Australia
 
112-7156710-1/1/1 07-Aug-2007 62ODC18 3002806906 Merck KGaA Germany
 
EQ6-0006348-9/1/1/B 14-Aug-2007 62QDJ08 3006289764 Edzer Simplice Haiti
 
112-7684361-4/1/1 27-Aug-2007 62TAP99 3006404561 Mistri Ivano Italy
 
112-7798281-7/1/1 27-Aug-2007 62UCB13 3003054821 Napp Pharmaceuticals United Kingdom
 
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