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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
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-8052126-5/1/1 05-Aug-2011 61ECA06 3004627510 Aventis Pharma Ltd India
 
112-0190913-7/1/1 24-Aug-2011 61ESY08 3004104647 Apin Chemiclas United Kingdom
 
112-6190659-2/1/2 19-Aug-2011 61FCA54 3002806462 Bayer Pharma AG Germany
 
UPS-2896064-5/1/1 01-Aug-2011 61GCA84 3009014872 Olga Lucia Lemos Colombia
 
BJE-0117828-5/1/1 04-Aug-2011 61GCS81 3003995556 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd China
 
BJE-0117877-2/1/1 04-Aug-2011 61GCS81 3003995556 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd China
 
F57-6091297-5/1/1 02-Aug-2011 61GDJ45 3003773810 Groupe Parima Inc. Canada
 
112-7168697-8/1/1 19-Aug-2011 61GIY71 3002806462 Bayer Pharma AG Germany
 
112-0728276-0/1/1 24-Aug-2011 61HCA43 3004766089 Landsteiner Scient Mexico
 
112-8052126-5/2/2 05-Aug-2011 61JCA16 3005584017 Ranbaxy Laboratories India
 
112-8052126-5/2/3 05-Aug-2011 61JCA16 3005584017 Ranbaxy Laboratories India
 
112-2883936-6/1/1 23-Aug-2011 61JDA16 3004367869 Ivanhoe Mines Ltd Canada
 
112-7305844-0/1/1 05-Aug-2011 61JDB08 3003719325 Ratiopharm Inc Canada
 
112-7305844-0/1/2 05-Aug-2011 61JDB08 3003719325 Ratiopharm Inc Canada
 
112-0899455-3/1/1 24-Aug-2011 61KAJ06 3003132519 Cuxson Gerrard & Co. Ltd. United Kingdom
 
112-1558861-2/1/1 23-Aug-2011 61LCB14 3008534738 Kestrel Medical United Kingdom
 
112-8031821-7/1/1 05-Aug-2011 61LCK29 3005167197 Sanofi-Aventis United States
 
112-2472193-1/1/1 10-Aug-2011 61MCB30 3008363465 Abbott Biotechnology Ltd United States
 
112-3405336-6/3/1 31-Aug-2011 61MCK06 3006170172 Roche Mexico
 
906-1097438-9/1/1 26-Aug-2011 61MCR24 3004101736 Harman Finochem Limited India
 
112-2483508-7/1/1 23-Aug-2011 61MIA38 3003411082 Glaxosmithkline United Kingdom
 
112-0608677-4/1/1 23-Aug-2011 61NIY80 1000543247 Toronto Research Chemicals Canada
 
112-0272356-0/1/1 24-Aug-2011 61NSY18 3007131258 Rl Fine Chem-Ii India
 
112-6028190-6/1/1 05-Aug-2011 61PAA99 3004916506 Servier Laboratories South Africa
 
112-3407611-0/2/1 31-Aug-2011 61PAN26 3004455088 Bristol-Myers Co Ltd United Kingdom
 
112-1381865-6/2/2 24-Aug-2011 61PCA31 3008125942 Glaxosmithkline Consumer Healthc United States
 
112-1381865-6/2/1 24-Aug-2011 61PCA31 3008125942 Glaxosmithkline Consumer Healthc United States
 
112-8052126-5/1/3 05-Aug-2011 61PCA55 3005564159 Franco Indian Pharm Pvt Ltd India
 
112-1381865-6/1/1 24-Aug-2011 61PCA99 3002807664 Merck Sharp & Dohme (Italia) S.p.A. Italy
 
112-1381865-6/1/2 24-Aug-2011 61PCA99 3002807664 Merck Sharp & Dohme (Italia) S.p.A. Italy
 
112-6264353-3/1/1 19-Aug-2011 61PCY17 3007684666 Sanofi Aventis France
 
112-7187076-2/1/1 19-Aug-2011 61QDK03 3002806979 Ferring GmbH Germany
 
112-1675484-1/1/1 23-Aug-2011 61TAC31 3006759484 Mcneil Products United Kingdom
 
UPS-3313186-9/1/1 11-Aug-2011 61TCA31 3009070222 Kim Keley Canada
 
UPS-3319650-8/1/5 23-Aug-2011 61TCA31 3009084842 Dale Heath Limited T/A The Heath Ph United Kingdom
 
112-0479617-6/1/1 23-Aug-2011 61TCB31 3008453954 Mcneil Products Ltd United Kingdom
 
231-1789513-0/1/1 24-Aug-2011 61TCF99 3002806873 Alkermes Pharma Ireland Ltd. (Elan) Ireland
 
231-1789513-0/1/2 24-Aug-2011 61TCF99 3002806873 Alkermes Pharma Ireland Ltd. (Elan) Ireland
 
112-3484930-0/1/1 24-Aug-2011 61TCS31 3002093078 Vasudha Pharma Chem Limited India
 
FY6-2008067-8/8/1 24-Aug-2011 61VAA01 3004135577 Novartis United States
 
112-2020642-4/1/3 24-Aug-2011 61VBL01 3008891325 Forest Laboratories United Kingdom
 
112-2020642-4/1/1 24-Aug-2011 61VBL99 3008891324 Dendron Limited United Kingdom
 
112-2533065-8/1/1 10-Aug-2011 61WDA52 3004747476 Consultorio Medicao Venezuela
 
112-0255045-0/1/1 24-Aug-2011 61WIY04 3008569178 Fagron Services Netherlands
 
510-6899673-8/1/1 09-Aug-2011 61WIZ38 3004556509 Yuki Gosei Kogyo Co. Ltd. Japan
 
FC7-0112068-3/3/1 04-Aug-2011 61XBY14 3003450399 Alphapharm Australia
 
112-7324537-7/1/1 05-Aug-2011 61XDY08 3007497376 Supriya Lifescience Ltd India
 
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