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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
112-7758514-7/1/1 28-Sep-2005 62CCB99 3005235004 Jaywadan Chawah India
 
112-7980309-2/1/1 02-Sep-2005 62CDB99 3004556128 Reckitt Bemckiser Plc United Kingdom
 
112-8277057-7/3/1 26-Sep-2005 62ECB99 3005305645 Boehringer Irigelheum Philippines
 
112-7668854-6/1/1 13-Sep-2005 62FAR99 3005220912 Amhk Sylla United Kingdom
 
AEK-6677792-7/1/1 27-Sep-2005 62FBO46 3003878710 Singapore Post Singapore
 
AR8-0029383-9/6/1/A 09-Sep-2005 62FCL20 3004706890 Ooo Protek-50 Russia
 
AR8-0029383-9/6/1/B 09-Sep-2005 62FCL20 3004706890 Ooo Protek-50 Russia
 
AR8-0029383-9/6/1/K 09-Sep-2005 62FDJ99 3004706890 Ooo Protek-50 Russia
 
AR8-0029383-9/6/1/M 09-Sep-2005 62FDL46 3004706890 Ooo Protek-50 Russia
 
112-7541297-1/1/1 08-Sep-2005 62GCA41 3003481013 Laboratorios Alfa, SRL Dominican Republic
 
112-7458467-1/1/1 08-Sep-2005 62GCA48 3002719066 PARKE-DAVIS & COMPANY Colombia
 
112-7307784-2/1/8 06-Sep-2005 62GCA94 3005165016 Vivax Venezuela
 
112-8060325-9/1/1 21-Sep-2005 62GCY18 3004834797 Laboratorios Jr Sanchex Sa Costa Rica
 
112-7934055-8/1/1 15-Sep-2005 62GCY90 3005027613 Novartis Egypt
 
AEK-6815591-6/1/1 09-Sep-2005 62GDA61 3005267760 Sam Pharmaceutical Ltd Nigeria
 
112-7307784-2/1/3 06-Sep-2005 62GDA90 3003766053 Novartis Nutrition De Venezuela Sa Venezuela
 
112-7980309-2/2/1 02-Sep-2005 62GDB86 3000149705 Drug Houses Of Australia Pte Ltd Singapore
 
BIE-0005027-2/5/1 02-Sep-2005 62GDJ83 3005208036 Mother Care Top Shop Cameroon
 
AR8-0029383-9/6/1/J 09-Sep-2005 62GDJ99 3004706890 Ooo Protek-50 Russia
 
WBA-1006531-5/25/1/A 19-Sep-2005 62GDJ99 3005056609 Protek 50 Russia
 
XXX-0125565-3/1/3 07-Sep-2005 62GDP18 1000203918 Merck Sharp & Dohme Mexico Mexico
 
AR8-0029383-9/6/1/N 09-Sep-2005 62HCA99 3004706890 Ooo Protek-50 Russia
 
M85-0042663-9/16/1/A 15-Sep-2005 62HDY99 3003155270 Chereles Audieulon Haiti
 
AEK-7058946-6/1/1 15-Sep-2005 62IAH99 3005266617 Foyo Herb China
 
AEK-6679777-6/1/1 20-Sep-2005 62IBE99 3005039906 Xian Cp Pharmaceutical Co Ltd China
 
112-7307784-2/1/1 06-Sep-2005 62KDA08 3005106102 Lab Pharma Venezuela Venezuela
 
AEK-7063156-5/1/1 23-Sep-2005 62LCA99 3001059001 Novartis International Ag Switzerland
 
112-7683598-0/1/1 13-Sep-2005 62LCE40 3002807910 Pharmachemie B.V. Netherlands
 
112-7623418-4/1/1 09-Sep-2005 62LDC49 3002807585 Mepha LLC Switzerland
 
AEK-7064283-6/1/1 21-Sep-2005 62LIA99 3001670824 Brecon Pharmaceuticals Limited United Kingdom
 
AEK-6678285-1/1/1 27-Sep-2005 62MBO08 3005255379 Tosen Foods Inc Philippines
 
AR8-0029383-9/6/1/E 09-Sep-2005 62MDJ99 3004706890 Ooo Protek-50 Russia
 
AR8-0029383-9/6/1/F 09-Sep-2005 62MDJ99 3004706890 Ooo Protek-50 Russia
 
AR8-0029383-9/6/1/G 09-Sep-2005 62MDJ99 3004706890 Ooo Protek-50 Russia
 
AR8-0029383-9/6/1/L 09-Sep-2005 62MDJ99 3004706890 Ooo Protek-50 Russia
 
AR8-0029383-9/6/1/C 09-Sep-2005 62MDL01 3004706890 Ooo Protek-50 Russia
 
112-7861316-1/1/1 15-Sep-2005 62OAB14 3005248872 Ihab Abou Elmagd Egypt
 
112-7527331-6/1/1 08-Sep-2005 62OAP15 3001910153 Novartis Pharmaceuticals United Kingdom
 
112-8203324-0/1/1 23-Sep-2005 62OBC22 3004637738 Roche Sa Venezuela
 
112-7343904-2/3/1 07-Sep-2005 62OCA28 1000203918 Merck Sharp & Dohme Mexico Mexico
 
112-7589111-7/1/3 08-Sep-2005 62OCA28 3002138892 Laboratorio Chile S.A. Chile
 
112-7950972-3/4/1 15-Sep-2005 62OCA29 3004576565 Laboratorios Leti Venezuela
 
112-7457447-4/8/1 08-Sep-2005 62OCB49 3005192091 Bayer Venezuela
 
KH5-0016642-7/1/1 22-Sep-2005 62OCS05 3005131464 European Directorate France
 
112-7967705-8/1/1 02-Sep-2005 62ODB44 3005264134 Gx Phils Philippines
 
112-8188050-0/1/1 26-Sep-2005 62ODB44 3000281296 Novartis Pharma Canada Canada
 
112-7846381-5/1/1 14-Sep-2005 62OIY24 3003930513 Ethypharm France
 
112-7935412-0/2/1 15-Sep-2005 62OQY18 2434498 Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) United States
 
112-7935412-0/2/2 15-Sep-2005 62OQY22 3004530401 Glaxo Smith Kline United States
 
112-7935412-0/1/2 15-Sep-2005 62OQY37 1000476214 Mead Johnson De Mexico/Bristol Myers de Mexico S.A. de C.V. Mexico
 
WBA-1006531-5/16/1 19-Sep-2005 62PDJ99 3005056609 Protek 50 Russia
 
112-7504346-1/1/1 08-Sep-2005 62TJB06 3002758317 Merial Limited Australia
 
AEK-7048323-1/1/1 15-Sep-2005 62UAL99 3005175682 Venus Shipping France
 
K80-0906566-6/11/1 19-Sep-2005 62UAY99 3004249920 FIDAI TRADING ENTERPRISE Pakistan
 
112-7307784-2/1/5 06-Sep-2005 62UCK14 3003967026 Pfizer Venezuela
 
AR8-0029383-9/1/1/B 09-Sep-2005 62UDA99 3004706890 Ooo Protek-50 Russia
 
AR8-0029383-9/1/1/C 09-Sep-2005 62UDA99 3004706890 Ooo Protek-50 Russia
 
WBA-1006531-5/25/1/C 19-Sep-2005 62UDA99 3005056609 Protek 50 Russia
 
112-7822828-3/1/1 14-Sep-2005 62VCB49 3005244094 Per Poulsen Denmark
 
112-7935313-0/1/1 15-Sep-2005 62VDC32 3003699941 Cipla Ltd India
 
045-0217348-9/3/1 23-Sep-2005 62WBY17 3002658178 Caa Omega Poland
 
112-7589491-3/1/3 09-Sep-2005 62YDP05 3005040688 Laboratorios Magnachem Cxa Dominican Republic
 
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