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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
UPS-7805905-5/3/1 17-Jun-2013 64ABL20 3007084136 Ningbo Unichem Household Products Co Ltd. China
 
UPS-0909758-7/1/1 07-Jun-2013 64GCY07 3010180733 Jhon Mario Hurtado Ramirez Colombia
 
UPS-0848975-1/1/2 07-Jun-2013 64GDY13 1000556091 Bayer Mexico S.A. de C.V. Mexico
 
336-0392255-4/1/1 27-Jun-2013 64JAV01 3019570 Praxair Inc United States
 
OHL-0230378-6/1/1 01-Jun-2013 64LAY38 3009845690 Josun International Ltd. Hong Kong SAR
 
M21-0748096-6/1/1 25-Jun-2013 64LCA41 3007522260 Lyka Bdr International Ltd India
 
M21-0748096-6/1/3 25-Jun-2013 64LCA41 3007522260 Lyka Bdr International Ltd India
 
M21-0748096-6/1/2 25-Jun-2013 64LCA41 3007522260 Lyka Bdr International Ltd India
 
UPS-1043266-6/1/1 18-Jun-2013 64LCY50 3010199857 Gustavo Castellano Canada
 
XXX-0167538-9/1/1 05-Jun-2013 64LDJ08 3002624237 Glaxo Saudi Arabia Ltd. Saudi Arabia
 
9ES-0015228-8/1/1 03-Jun-2013 64LQY37 3001164052 Henan Lihua Pharmaceutical Co., Ltd. China
 
XXX-0181315-2/1/1 12-Jun-2013 64R99 3005761912 Bbt Biotech Gmbh Germany
 
UPS-1338240-5/1/1 27-Jun-2013 64RCY22 2244771 Novo Nordisk, Inc. United States
 
112-2862214-4/1/1 11-Jun-2013 64TDT08 3008939829 Concord Biotech Li India
 
UPS-0966723-1/2/1 13-Jun-2013 64XBL06 3010207596 Stiefel, a GSK company United Kingdom
 
M21-0748109-7/1/1 10-Jun-2013 64XBR06 3006094247 Research Pharmaceutical Co Ltd China
 
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