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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-7050141-2/1/2 08-Jul-2005 61EAA99 3004436354 Dr P D Gupta India
 
AEK-7050141-2/1/1 08-Jul-2005 61EAL99 3004436354 Dr P D Gupta India
 
112-7301563-6/2/1 25-Jul-2005 61ECP08 3000270594 Scheramex S A De C V Mexico
 
112-7156201-9/1/1 22-Jul-2005 61EDY04 3005149331 Lab Astra Zeneca Ab Colombia
 
AEK-7045049-5/1/1 01-Jul-2005 61EIS06 3003202659 Dr. Reddy's Laboratories Ltd., Generics India
 
AEK-6670425-1/1/1 28-Jul-2005 61FAE54 3005176153 Jael Albacete Philippines
 
M21-0731272-2/1/1 28-Jul-2005 61FCA55 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
AEK-6578830-5/1/2 08-Jul-2005 61FCK54 3005187236 Pradeep Shrestha Nepal
 
112-7529157-3/1/1 20-Jul-2005 61GDY50 3003899848 Unilab Philippines
 
BGK-0024121-7/22/1 28-Jul-2005 61HBQ99 3000481362 Kinesys Pharmaceutical Inc. Canada
 
112-7219541-3/2/1 22-Jul-2005 61HCA43 3003948502 Janssen Cilag S.A. De C.V. Mexico
 
310-9079009-3/1/1 14-Jul-2005 61HCC18 3002808032 Warner Chilcott Deutschland GmbH Germany
 
310-9078996-2/1/1 29-Jul-2005 61HCC18 3002808032 Warner Chilcott Deutschland GmbH Germany
 
112-7342167-7/1/1 25-Jul-2005 61HCJ18 3005176014 Rbtt Services Ltd Trinidad & Tobago
 
112-7158403-9/1/1 22-Jul-2005 61HCY99 3003183014 Mrw Venezuela
 
112-7395190-5/1/1 05-Jul-2005 61HDB03 3005183613 Roche Philippines Inc Philippines
 
032-0333571-0/1/1 19-Jul-2005 61IIJ99 3004932646 Aurolab Aravind Eye Hospital India
 
112-7008359-5/1/1 18-Jul-2005 61JCB08 3004962072 Pfizer Ilaclari A.S. Turkey
 
112-7015931-2/1/1 18-Jul-2005 61JCB99 3004962072 Pfizer Ilaclari A.S. Turkey
 
AEK-7050957-1/1/1 29-Jul-2005 61JCP99 3005197276 Flora Minas Armenia
 
AEK-6667468-6/1/3 20-Jul-2005 61JDA08 3005127126 Nestor Chua Philippines
 
112-6954583-6/1/5 25-Jul-2005 61JDA08 3003864349 Pfizer Indonesia Pt Indonesia
 
AEK-6669392-6/1/2 06-Jul-2005 61JDA10 3005157219 Lalaine Salarda Philippines
 
112-7144213-9/1/1 21-Jul-2005 61KCA40 3004426110 Aventis Pharma S.A Mexico
 
112-7033174-7/4/2 20-Jul-2005 61LDY38 3003308056 Sanofi Synthelabo France
 
AEK-7050418-4/1/1 08-Jul-2005 61MCE06 3004421377 Louna Tgravel Lebanon
 
310-9690085-2/2/1 18-Jul-2005 61MDC06 3002927489 Guardian Wishing Well Pharmacy Canada
 
112-7008411-4/1/1 18-Jul-2005 61NCB74 3004509131 Cephalon France France
 
112-7008184-7/1/1 18-Jul-2005 61NCC83 3005133899 Lundeck Pharma A/S Denmark
 
AEK-7050418-4/2/1 08-Jul-2005 61NCE24 3004421377 Louna Tgravel Lebanon
 
112-7033174-7/4/3 20-Jul-2005 61NCY82 3004361877 Janssen Cilag France
 
112-7298976-5/2/1 25-Jul-2005 61NIY69 3005168850 Anzen Exports India
 
AEK-7046719-2/1/1 26-Jul-2005 61PCA31 3005161365 Said Ahmed El Ajou Saudi Arabia
 
112-7012177-5/1/1 19-Jul-2005 61PCP26 3005128068 Alexanders Pharmacy United Kingdom
 
112-7158796-6/1/1 22-Jul-2005 61PCP99 3004166856 Bayer Diagnostics France
 
112-7158796-6/1/2 22-Jul-2005 61PCP99 3003414667 Laboratoire Aventis France
 
112-7158796-6/1/3 22-Jul-2005 61PCP99 3005149751 Achi Sosthene France
 
112-7184382-3/1/1 22-Jul-2005 61PIY99 3005153092 Vwr Int Switzerland
 
112-7144213-9/1/2 21-Jul-2005 61TCA08 3005147411 Glaxosmith Kline Mexico
 
AEK-7046939-6/1/1 25-Jul-2005 61TIS16 3002807260 Trifarma S.p.A. Italy
 
112-7031631-8/1/2 20-Jul-2005 61UCA05 3005131494 Maria Arlas Panama
 
112-7301563-6/1/1 25-Jul-2005 61WCP52 2210396 Novartis Pharmaceuticals Corp. United States
 
112-7008500-4/1/1 18-Jul-2005 61WDB52 3005125592 F Frik Turkey
 
112-7225516-7/1/1 06-Jul-2005 61XCY99 3004364173 Aventis Pharma Sa Guatemala
 
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