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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
110-5168468-8/2/1 15-Mar-2005 64ABL20 3003101044 Avmor Canada
 
110-5119819-2/2/1 28-Mar-2005 64ABL20 3003101044 Avmor Canada
 
077-4004865-2/2/1 09-Mar-2005 64BAR43 3003297374 Canton Laboratories Pvt. Ltd. India
 
AEK-7029745-8/2/1 23-Mar-2005 64BCA04 3005023955 K Jayesh India
 
112-5783703-9/1/1 04-Mar-2005 64BCA24 3004950961 Jaime Saenz S Mexico
 
112-5954089-6/1/2 14-Mar-2005 64BCY48 3004576566 Laboratories Vivax Venezuela
 
WRE-0327214-3/7/1 16-Mar-2005 64BCZ25 3008251350 Suzhou Lixin Pharmaceutical Co. Ltd. China
 
112-5693636-0/1/3 04-Mar-2005 64BDB25 3002906944 Apotex Inc. Canada
 
112-6069375-9/1/1 29-Mar-2005 64HAA01 3004989626 Teva Sante France
 
ALA-0005480-1/1/1 07-Mar-2005 64HBH02 3002989060 Procaps S.A. Colombia
 
ATK-3002278-5/1/1 28-Mar-2005 64HCY02 3004770647 Lianyungang Jf International Trade China
 
112-5940818-5/3/1 14-Mar-2005 64HDA02 3004512630 Grupo Roche Syntex De Mixixo Sa Mexico
 
112-6321479-3/4/1 14-Mar-2005 64LAA03 3005027611 Eipi Company Egypt
 
389-0034500-0/2/1 05-Mar-2005 64LAR38 3003809921 SJZ Chem-Pharm Co., Ltd. China
 
ER2-2500255-5/1/1 28-Mar-2005 64LAS38 419 Tianjin Tianyao Pharmaceuticals Co. China
 
112-6313071-8/2/2 23-Mar-2005 64LAY08 3002807078 GlaxoSmithKline United Kingdom
 
112-6250102-6/1/1 29-Mar-2005 64LCA60 3004534358 Laboratorios Diba, S.A. Mexico
 
H67-1248863-3/3/1/J 23-Mar-2005 64LCJ67 3004074880 Pramil Srl Italy
 
H67-1248863-3/3/1/M 23-Mar-2005 64LCJ67 3009853808 Beltapharma SPA Subsidary of Strides Arcolab International Italy
 
791-2446781-6/2/1 30-Mar-2005 64LCL06 3004622712 Ivax Pharmaceutical Mexico Mexico
 
112-6313071-8/2/1 23-Mar-2005 64LCO67 3002807078 GlaxoSmithKline United Kingdom
 
112-6313071-8/1/2 23-Mar-2005 64LCO67 3002879170 Glaxo Welcome Gmbh & Co Germany
 
112-5716999-5/1/1 04-Mar-2005 64LDO06 1000386375 Schering Plough Sa De Cv Mexico
 
112-6210828-5/1/2 30-Mar-2005 64LDY99 3002806285 Allergan Pharmaceuticals Ireland Ireland
 
112-5783552-0/1/1 04-Mar-2005 64MAA01 3004950960 Abascal Ismael Mexico
 
112-5783608-0/1/1 04-Mar-2005 64MCA01 3004950853 Abel Quintana H Mexico
 
114-0182785-9/1/1 28-Mar-2005 64MCS04 3002806821 MSD Organon BV Netherlands
 
112-5911823-0/1/1 14-Mar-2005 64MDY07 3004968275 Industria Farmaceutica Serono Sp Italy
 
112-5662416-4/1/1 03-Mar-2005 64RCA21 3004934801 Industria Farmaceutica Mexico
 
AEK-7027830-0/1/1 28-Mar-2005 64RCP22 3000235541 Lilly S.A. Spain
 
XXX-0102674-0/1/1 07-Mar-2005 64RDL99 3000215185 BPR Health International United States
 
119-0033984-4/40/1 29-Mar-2005 64RIB99 3004950793 Walter O. Valverde Cordova Bolivia
 
112-5992953-7/1/1 17-Mar-2005 64RIY18 3004979475 Renaissance Medica Bahamas
 
112-5940818-5/2/1 14-Mar-2005 64UCA02 1000556091 Bayer Mexico S.A. de C.V. Mexico
 
112-5783469-7/1/1 04-Mar-2005 64UCA99 3004950845 Antonio Flores Mexico
 
112-6321479-3/4/2 14-Mar-2005 64XAO12 3005027613 Novartis Egypt
 
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