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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-7853274-6/1/1/A 26-Jul-2010 62CBL41 3008408357 Lelalee Pharmaceutica Laboratori Philippines
 
112-7853274-6/1/1/B 26-Jul-2010 62CBL41 3008408357 Lelalee Pharmaceutica Laboratori Philippines
 
112-9730759-0/1/1 26-Jul-2010 62CDL39 3005050395 Seratec France
 
112-9176169-3/1/1 22-Jul-2010 62FCL08 3007564559 North Meol Pharmacy United Kingdom
 
112-9267339-2/2/1 22-Jul-2010 62FIY99 3007588151 Quintiles United Kingdom
 
336-3870455-4/1/1 22-Jul-2010 62G99 3007190503 Kedo Euromedics Kft Hungary
 
336-3870455-4/1/2 22-Jul-2010 62G99 3007190503 Kedo Euromedics Kft Hungary
 
M21-0742074-9/1/1 29-Jul-2010 62GBA41 3006094247 Research Pharmaceutical Co Ltd China
 
112-9251823-3/2/1 22-Jul-2010 62GCB56 3006363944 Weifa AS Norway
 
112-9473587-6/3/1 26-Jul-2010 62GCJ17 3007908018 Laboratoires Roussel France
 
M21-0741829-7/3/1 01-Jul-2010 62GDL18 3008367099 Shanghai Trifecta Pharma Ltd. China
 
M21-0741829-7/6/1 01-Jul-2010 62GDL18 3008367099 Shanghai Trifecta Pharma Ltd. China
 
UPS-2112948-5/1/1 08-Jul-2010 62GIA99 3008196528 Greenstone Llc United States
 
004-5607648-8/1/1 19-Jul-2010 62IIS99 3002807086 GlaxoSmithKline Inc. Canada
 
AEK-8015715-5/3/1 28-Jul-2010 62KCA10 3008315229 Sandeep Siwach India
 
T94-0052884-8/1/1 14-Jul-2010 62KIY10 3006194839 Rashmi Pharma Pvt Ltd India
 
W13-4238671-3/6/1 07-Jul-2010 62MBL99 3003274380 Bryson Garden Remedies Canada
 
W13-4238845-3/6/1 07-Jul-2010 62MBL99 3003274380 Bryson Garden Remedies Canada
 
AEK-8273680-8/1/3 23-Jul-2010 62OCA05 3006802781 Sharma Healing Kapurthala India
 
AEK-8019191-5/1/1 28-Jul-2010 62OCA37 3008377676 Rauachandran India
 
AEK-8015715-5/1/1 28-Jul-2010 62OCA41 3008315229 Sandeep Siwach India
 
EG6-1821731-9/1/1 28-Jul-2010 62OCA41 3005466325 Apotex Pharmachem India Pvt Ltd. India
 
EG6-1821737-6/1/1 28-Jul-2010 62OCA41 3005466325 Apotex Pharmachem India Pvt Ltd. India
 
EG6-1821834-1/1/1 28-Jul-2010 62OCA41 3005466325 Apotex Pharmachem India Pvt Ltd. India
 
AEK-8273680-8/1/5 23-Jul-2010 62OCA43 3006802781 Sharma Healing Kapurthala India
 
112-9537706-6/1/2 26-Jul-2010 62OCC22 3002807086 GlaxoSmithKline Inc. Canada
 
EG6-1821732-7/1/1 28-Jul-2010 62ODA41 3005466325 Apotex Pharmachem India Pvt Ltd. India
 
EG6-1821920-8/2/1 28-Jul-2010 62ODA41 3005466325 Apotex Pharmachem India Pvt Ltd. India
 
EG6-1821920-8/1/1 28-Jul-2010 62ODA41 3005466325 Apotex Pharmachem India Pvt Ltd. India
 
EG6-1821920-8/3/1 28-Jul-2010 62ODA41 3005466325 Apotex Pharmachem India Pvt Ltd. India
 
EG6-1821963-8/1/1 28-Jul-2010 62ODA41 3005466325 Apotex Pharmachem India Pvt Ltd. India
 
112-9253081-6/1/1 22-Jul-2010 62OIA37 3007007549 Bluepharma Industria Farmaceutica, S.A. Portugal
 
112-9253081-6/2/1 22-Jul-2010 62OIA37 3007867973 Bristol Myers Squibb United States
 
AEK-8016968-9/1/1 09-Jul-2010 62OIA43 3008337831 Sahukat Cyclewalla India
 
AEK-8017225-3/1/2 28-Jul-2010 62QCB99 3008343153 Gilles France
 
AEK-8273680-8/1/6 23-Jul-2010 62TCA07 3006802781 Sharma Healing Kapurthala India
 
112-9565040-5/1/1 26-Jul-2010 62TCP02 3005811260 Janssen Cilag Famacutica Brazil
 
T94-0052884-8/2/1 14-Jul-2010 62TCS02 3006194839 Rashmi Pharma Pvt Ltd India
 
112-9547968-0/2/1/A 26-Jul-2010 62UCY99 3005167197 Sanofi-Aventis United States
 
112-9547968-0/2/1/B 26-Jul-2010 62UCY99 3005167197 Sanofi-Aventis United States
 
BUP-1512883-1/1/1 01-Jul-2010 62VDA12 3005792504 Almac Clinical Services, Ltd. United Kingdom
 
045-0284536-7/5/1 20-Jul-2010 62WBY17 3002658178 Caa Omega Poland
 
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