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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 61-Human and Animal Drugs

Entry/doc/line/sfx Refusal Date Product
M21-0736550-6/8/1 10-Oct-2007 61EAA08 3006497359 Research Pharmaceutical Colombia
112-8790669-9/1/1/A 30-Oct-2007 61EBA08 3003693184 Schering Plough Europe Belgium
112-8790669-9/1/1/C 30-Oct-2007 61ECQ04 3005615782 Astra Zeneca Kft Hungary
112-7687530-1/1/1 05-Oct-2007 61FIY54 3002906944 Apotex Inc. Canada
M21-0736550-6/2/1 10-Oct-2007 61GAA57 3006497359 Research Pharmaceutical Colombia
112-6857173-6/1/1 04-Oct-2007 61HCB99 3004459800 Glaxosmithkline Pharmaceuticals India
H77-0107433-5/1/1 30-Oct-2007 61HDS03 3003385723 Inventa Chemicals Ltd India
112-8485259-9/1/1 12-Oct-2007 61KCB16 3004553679 Roche Spa Italy
112-8381510-0/1/1 18-Oct-2007 61LCP99 3002989060 Procaps S.A. Colombia
112-8287624-4/1/3 02-Oct-2007 61LDP26 3003064821 Abbott Laboratories United States
M21-0736592-8/1/1 16-Oct-2007 61NAA29 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
112-7757799-7/1/1 04-Oct-2007 61PAY17 3003596612 Sanofi-Aventis U.S. LLC United States
112-8307009-4/1/2 18-Oct-2007 61PBA55 3003255171 Usv Limited India
112-8598887-1/1/1 22-Oct-2007 61PBA99 3003590955 Om Pharma Meyrin Switzerland
112-8287624-4/1/4 02-Oct-2007 61QDP03 3003596612 Sanofi-Aventis U.S. LLC United States
112-8689736-0/2/2 25-Oct-2007 61SBJ99 3004268929 Serf to Surf products Incorporated Canada
110-0442929-2/1/5 26-Oct-2007 61WAJ47 3003319427 Janssen Cilag Sa De Cv Mexico
M21-0736550-6/6/1 10-Oct-2007 61WBA04 3006497359 Research Pharmaceutical Colombia
M21-0736550-6/1/1 10-Oct-2007 61WCA47 3006497359 Research Pharmaceutical Colombia
112-8287592-3/2/1 02-Oct-2007 61WCA52 3006467535 Manaa Maher Tunisia
112-8442116-3/2/1 11-Oct-2007 61XAB45 3005792363 Glaxosmith Kline Philippines
M21-0736550-6/5/1 10-Oct-2007 61XBA45 3006497359 Research Pharmaceutical Colombia