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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
F11-2361756-7/1/1 20-Mar-2002 64BIA24 3003281078 Pharmaceutical Profiles United Kingdom
 
XXX-0026745-1/1/22 01-Mar-2002 64GDB29 3003501150 unknown Guyana
 
582-9251429-5/1/1 16-Mar-2002 64HAR02 3003446831 Fludan Fine Chemicals Inc Canada
 
XXX-0026745-1/1/5 01-Mar-2002 64HBL02 1000164985 Seton Healthcare Group United Kingdom
 
XXX-0044679-0/2/1 25-Mar-2002 64HBL99 3003580777 Bionatus Laboratorio Botanico Ltda. Brazil
 
M05-0323674-3/1/1 08-Mar-2002 64HDL99 3002825550 Smihtkline Beecham International (Panama), S.A. Panama
 
M05-0323674-3/2/1 08-Mar-2002 64HDL99 3002825550 Smihtkline Beecham International (Panama), S.A. Panama
 
M05-0323674-3/3/1 08-Mar-2002 64HDL99 3002825550 Smihtkline Beecham International (Panama), S.A. Panama
 
M05-0323674-3/4/1 08-Mar-2002 64HDL99 3002825550 Smihtkline Beecham International (Panama), S.A. Panama
 
M05-0323674-3/5/1 08-Mar-2002 64HDL99 3002825550 Smihtkline Beecham International (Panama), S.A. Panama
 
M05-0323674-3/7/1 08-Mar-2002 64HDL99 3002825550 Smihtkline Beecham International (Panama), S.A. Panama
 
M05-0323449-0/1/1 22-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0323449-0/2/1 22-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0323449-0/3/1 22-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0323449-0/4/1 22-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0323449-0/5/1 22-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0109004-3/1/1 22-Mar-2002 64HDL99 1000174169 Smithkline Beecham United Kingdom
 
M05-0108939-1/1/1 22-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0108973-0/1/1 22-Mar-2002 64HDL99 3002952995 Smithkline Beecham Costa Rica S.A. Costa Rica
 
M05-0108974-8/1/1 22-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0108978-9/1/1 22-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0108923-5/1/1 22-Mar-2002 64HDL99 3002875226 Glaxo Smithkline - Rixensart Belgium
 
M05-0108736-1/1/1 25-Mar-2002 64HDL99 3002825550 Smihtkline Beecham International (Panama), S.A. Panama
 
M05-0108795-7/1/1 25-Mar-2002 64HDL99 3002952995 Smithkline Beecham Costa Rica S.A. Costa Rica
 
M05-0108818-7/1/1 25-Mar-2002 64HDL99 3002807132 Glaxo Wellcome Spain Sa Spain
 
M05-0108822-9/1/1 25-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0108932-6/1/1 25-Mar-2002 64HDL99 1000174169 Smithkline Beecham United Kingdom
 
M05-0108932-6/2/1 25-Mar-2002 64HDL99 1000174169 Smithkline Beecham United Kingdom
 
M05-0109046-4/1/1 25-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0109048-0/1/1 25-Mar-2002 64HDL99 3003262904 Glaxo Operations UK Limited United Kingdom
 
M05-0109045-6/1/1 25-Mar-2002 64HDL99 3002825550 Smihtkline Beecham International (Panama), S.A. Panama
 
M05-0323748-5/1/1 27-Mar-2002 64HDL99 1000174169 Smithkline Beecham United Kingdom
 
M05-0323748-5/2/1 27-Mar-2002 64HDL99 1000174169 Smithkline Beecham United Kingdom
 
M05-0109079-5/1/1 28-Mar-2002 64HDL99 3003724366 Glaxo Smith Kline Panama S.A. Panama
 
M05-0109084-5/1/1 28-Mar-2002 64HDL99 1000174169 Smithkline Beecham United Kingdom
 
M05-0109092-8/1/1 28-Mar-2002 64HDL99 3002875226 Glaxo Smithkline - Rixensart Belgium
 
M05-0109085-2/1/1 28-Mar-2002 64HDL99 1000174169 Smithkline Beecham United Kingdom
 
F11-2362437-3/2/1 30-Mar-2002 64LDA19 3003605157 Anigeta Indonesia
 
XXX-0043616-3/1/4 25-Mar-2002 64RCM99 3003537163 Rottapharm S.r.l. Italy
 
XXX-0043616-3/1/1 25-Mar-2002 64RCP99 3003560844 Ferring SpA Italy
 
XXX-0043616-3/1/2 25-Mar-2002 64RCP99 3000298408 Serono Pharma S.P.A. Italy
 
XXX-0043616-3/1/3 25-Mar-2002 64RCP99 3003560812 Takeda Italia Italy
 
XXX-0044286-4/1/1 25-Mar-2002 64RCP99 3002894254 Farmacia Cerati Italy
 
XXX-0044291-4/1/1 25-Mar-2002 64RCP99 3002894254 Farmacia Cerati Italy
 
XXX-0044291-4/1/2 25-Mar-2002 64RCP99 3002894254 Farmacia Cerati Italy
 
XXX-0044294-8/1/1 25-Mar-2002 64RCP99 3002894254 Farmacia Cerati Italy
 
XXX-0044303-7/1/1 25-Mar-2002 64RCP99 3000298408 Serono Pharma S.P.A. Italy
 
XXX-0044303-7/1/2 25-Mar-2002 64RCP99 3003560844 Ferring SpA Italy
 
XXX-0044303-7/1/3 25-Mar-2002 64RCP99 3003560812 Takeda Italia Italy
 
XXX-0044277-3/1/1/M 07-Mar-2002 64TCL03 3003120129 Searle Pakistan Ltd Pakistan
 
110-7982988-3/1/1 19-Mar-2002 64VIR99 1021259 Microbac Laboratories Inc., Wilson Division United States
 
110-7982999-0/1/1 19-Mar-2002 64VIR99 3003537527 Idun Pharmaceuticals United States
 
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