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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
AEK-8017885-4/5/6 18-Aug-2010 61CAA99 3005543404 P Banerji Mihijam Pharmaceuticals India
 
DN1-0080166-6/1/6 03-Aug-2010 61EBA99 3004389904 WUZHOU RFX COMPANY China
 
DN1-0080166-6/1/5 03-Aug-2010 61EBH99 3004389904 WUZHOU RFX COMPANY China
 
DN1-0080166-6/1/22 03-Aug-2010 61EBH99 3004389904 WUZHOU RFX COMPANY China
 
112-8051808-8/1/1 06-Aug-2010 61EDQ04 3002808171 Sigma Tau S.p.A. Italy
 
M21-0742108-5/1/1 31-Aug-2010 61GAA57 3003649250 Virchow Laboratories Ltd. India
 
M21-0741875-0/1/1 03-Aug-2010 61GCL80 3007522260 Lyka Bdr International Ltd India
 
DN1-0080166-6/1/20 03-Aug-2010 61HBH99 3004389904 WUZHOU RFX COMPANY China
 
112-9320880-0/1/1 31-Aug-2010 61JAB08 1000607714 Pfizer Canada Inc Canada
 
AEK-8017885-4/5/2 18-Aug-2010 61LAA99 3005543404 P Banerji Mihijam Pharmaceuticals India
 
XXX-0260210-1/1/1 03-Aug-2010 61LCP29 1000610805 Sanofi Winthrop Industrie France
 
XXX-0259576-8/1/1 04-Aug-2010 61LCY29 1000610805 Sanofi Winthrop Industrie France
 
112-7842649-2/1/1 11-Aug-2010 61MCA99 3006686646 Ovation Pharmaceuticals Canada
 
112-9490818-4/1/1 02-Aug-2010 61MCS37 3007135407 J P N Pharma Pvt Ltd India
 
112-9300014-0/2/1 10-Aug-2010 61NCA65 3007532190 Mint Pharmacueticals Inc Canada
 
112-9300014-0/2/2 10-Aug-2010 61NCA65 3007532190 Mint Pharmacueticals Inc Canada
 
231-9694583-9/1/1 03-Aug-2010 61NCS69 3003901862 Pfizer Asia Pacific Pte Ltd. Singapore
 
XXX-0197993-0/1/3 06-Aug-2010 61NDY69 3006684202 Laboratorios Laprin Guatemala
 
112-9369903-2/1/1/B 10-Aug-2010 61PDR99 3007891901 Mahd Azmath India
 
DN1-0080166-6/1/16 03-Aug-2010 61QBH99 3004389904 WUZHOU RFX COMPANY China
 
AEK-8308942-1/1/1 23-Aug-2010 61TCY31 3002093078 Vasudha Pharma Chem Limited India
 
AEK-8017885-4/2/1 18-Aug-2010 61VAA99 3005543404 P Banerji Mihijam Pharmaceuticals India
 
AEK-8352108-4/2/1 26-Aug-2010 61XCC45 3008433886 P A Anish India
 
113-5235526-4/1/1/B 13-Aug-2010 61XCS04 3003677831 Keshava Organics Pvt. Ltd. India
 
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