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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
AEK-0123127-9/1/1 11-May-2012 61ECY08 3009442281 Beijing Sl Pharmaceutical China
551-0208364-5/1/1 23-May-2012 61GCS45 3007619914 Yangzhou Tianhe Pharmaceutical Co., Ltd. China
700-0133740-4/1/1 22-May-2012 61HOS11 3007231089 Wujiang Bolin Industry Co., Ltd China
112-8525752-7/1/1 30-May-2012 61JCC08 3007712483 Pirmal Healthcare Ltd India
112-0215448-5/1/1 31-May-2012 61JCC11 3008688666 Gemfibronilo Labs Tecnoquimicas Colombia
UPS-6085754-3/1/2 09-May-2012 61JCY08 3009497979 Atlas Energy Systems, S.L. Spain
112-7110654-9/1/2 23-May-2012 61JDB14 3005673040 TEVA UK Limited United Kingdom
XXX-0284848-0/1/11 16-May-2012 61JDY08 3005653467 Genfar Sa Colombia
112-8172268-0/1/1 31-May-2012 61KBA40 3006549683 Sanofi Aventis Parmaceutica Ltda Brazil
112-9955602-1/1/1 31-May-2012 61LCA13 3008648357 Ophalac Colombia
KH5-0072626-1/2/1 10-May-2012 61LIS99 3002806556 Boehringer Ingelheim Pharma GmbH & Co. KG Germany
KH5-0072626-1/1/1 10-May-2012 61LIS99 3002806556 Boehringer Ingelheim Pharma GmbH & Co. KG Germany
112-7385323-9/2/1 23-May-2012 61MAB41 3003338219 Astec Uk United Kingdom
AEK-0278750-1/1/3 31-May-2012 61NAA78 3009510221 Farmaceutica Resp Elaine Pereira Cavassani Brazil
AEK-0300452-6/2/1 14-May-2012 61PCA55 3009478116 Ateef Abd Egypt
112-0215448-5/1/2 31-May-2012 61PCC11 3008206286 Labs Roche Colombia
XXX-0284848-0/1/9 16-May-2012 61PCY55 3008251123 Winthrop Pharmaceuticals Colombia
112-7110654-9/2/1 23-May-2012 61PDB31 3009161444 Bristol Laboratories Ltd United Kingdom
112-7430794-6/1/1 16-May-2012 61PIE99 3009438490 Health Herbal Products Pvt. Ltd. India
AEK-0278750-1/1/4 31-May-2012 61TAA03 3009510219 Laboratorio Sanofi Brazil
112-8579439-6/1/4 30-May-2012 61TAA17 3008490617 Anupamaa India
AEK-0114525-5/1/3 31-May-2012 61TDY31 3009432460 Dr Mohammed Siraj India