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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
112-0057856-7/3/1 20-Jan-2006 62ACB03 3005531498 Novartis Pharmaceuticals P/L Australia
 
AEK-7085556-0/1/3 13-Jan-2006 62CAA99 3005512578 Maeer China
 
AEK-7085556-0/1/1 13-Jan-2006 62CAE99 3005512578 Maeer China
 
AEK-7085556-0/1/2 13-Jan-2006 62CAE99 3005512578 Maeer China
 
112-0059960-5/1/1 27-Jan-2006 62CCC99 3004614219 Solvay Pharma Inc Phils Philippines
 
112-0059960-5/1/2 27-Jan-2006 62CCC99 3004622445 Janssen Pharmaceutica Philippines
 
AYG-1000635-6/29/1 04-Jan-2006 62FAJ99 3003485744 P. P. Overseas India
 
AYG-1000635-6/30/1 04-Jan-2006 62FAJ99 3003485744 P. P. Overseas India
 
AYG-1000635-6/31/1 04-Jan-2006 62FAJ99 3003485744 P. P. Overseas India
 
144-5435767-6/1/1/A 26-Jan-2006 62FAQ23 3001956890 Assured Packaging Inc. Canada
 
112-8880635-8/1/1 31-Jan-2006 62FOY99 3005522553 Galdrema Phils Inc Philippines
 
AYG-1000635-6/33/1 04-Jan-2006 62GAL99 3003485744 P. P. Overseas India
 
AYG-1000635-6/34/1 04-Jan-2006 62GAL99 3003485744 P. P. Overseas India
 
AYG-1000635-6/35/1 04-Jan-2006 62GAL99 3003485744 P. P. Overseas India
 
112-8697280-6/1/1 18-Jan-2006 62GAR99 3005498936 Balden Managat United Kingdom
 
XXX-0136683-1/1/1/C 10-Jan-2006 62GBB50 3004101733 Tecnandina S.A. Ecuador
 
DO7-0100278-7/2/1 17-Jan-2006 62GBL99 3005432785 Unrwa Jordan
 
AEK-7085561-0/3/1 13-Jan-2006 62GCA86 3003211866 Welbeck Pharmacy United Kingdom
 
112-8533431-3/1/1 06-Jan-2006 62GCB99 3005476155 Novartis Healthcare Philippines
 
112-8845054-6/2/1 18-Jan-2006 62GCJ99 3005084840 Pfizer Consumer Healthcare Australia
 
AEK-7076978-7/1/1 14-Jan-2006 62GCL18 3005434147 Sargam Save India
 
XXX-0137118-7/1/1/A 20-Jan-2006 62GDK18 3004605529 Vitrofarma Sa Colombia
 
112-8882098-7/1/1 18-Jan-2006 62GDP18 3003183014 Mrw Venezuela
 
112-8882098-7/1/2 18-Jan-2006 62GDP18 3003183014 Mrw Venezuela
 
112-8882098-7/1/3 18-Jan-2006 62GDP18 3003183014 Mrw Venezuela
 
112-8882098-7/1/4 18-Jan-2006 62GDP18 3003183014 Mrw Venezuela
 
112-8882098-7/1/5 18-Jan-2006 62GDP18 3003183014 Mrw Venezuela
 
112-8882098-7/1/6 18-Jan-2006 62GDP18 3003183014 Mrw Venezuela
 
112-8623277-1/2/2 18-Jan-2006 62GIA99 1000148101 UPM Pharmaceuticals United States
 
AEK-7081520-0/1/1 17-Jan-2006 62IBA99 3005476070 Vardya Balendu Prakash India
 
112-0030997-1/1/1 23-Jan-2006 62IBB99 3005874543 The Herbal Spirit United States
 
AEK-7081520-0/1/4 17-Jan-2006 62IBF99 3005476070 Vardya Balendu Prakash India
 
AEK-7081520-0/1/2 17-Jan-2006 62IBR99 3005476070 Vardya Balendu Prakash India
 
AEK-7081520-0/1/3 17-Jan-2006 62IBR99 3005476070 Vardya Balendu Prakash India
 
112-8637832-7/1/1 23-Jan-2006 62IIK31 3004208930 Clinical Trial Services United States
 
112-0125275-8/1/1 30-Jan-2006 62IIL86 3005538998 Terono Canada Canada
 
AEK-6037326-9/2/1 05-Jan-2006 62KAA08 3003081334 Conseil De L'Europe France
 
XXX-0136714-4/1/4 10-Jan-2006 62LCB40 3004175446 Ruipharma , S.A. Guatemala
 
112-8763457-9/1/1 18-Jan-2006 62LCP99 3002803743 GlaxoSmithKline Inc United States
 
411-4121131-2/11/2/B 06-Jan-2006 62LQY01 3000939205 Apotheek Jorissen Nv Belgium
 
411-4121131-2/11/1 06-Jan-2006 62LRA99 3000939205 Apotheek Jorissen Nv Belgium
 
AEK-7085561-0/2/3 13-Jan-2006 62OCA22 3003211866 Welbeck Pharmacy United Kingdom
 
112-8792586-0/1/1 25-Jan-2006 62OCA24 3005510216 S. Ram Kumar India
 
AEK-7085108-0/1/1 18-Jan-2006 62OCA28 3005509066 P.R. Bakker Netherlands
 
AEK-7085561-0/2/1 13-Jan-2006 62OCA41 3003211866 Welbeck Pharmacy United Kingdom
 
112-0132386-4/1/1 24-Jan-2006 62ODB15 3005539986 Pfizer Consumer Health United States
 
AYG-1000635-6/37/1 04-Jan-2006 62SAL99 3003485744 P. P. Overseas India
 
AYG-1000635-6/38/1 04-Jan-2006 62SAL99 3003485744 P. P. Overseas India
 
K80-0913918-0/17/1 12-Jan-2006 62SAL99 3004348364 P. J. Exports India
 
XXX-0136714-4/1/1 10-Jan-2006 62TCB02 3005035920 Caplin Point Laboratories Ltd India
 
XXX-0136714-4/1/2 10-Jan-2006 62TCB02 3005035920 Caplin Point Laboratories Ltd India
 
112-8700936-8/4/1 18-Jan-2006 62UCY99 3005499067 Pt Artois Pharmaceutical Ind. Indonesia
 
112-8753119-7/1/1 25-Jan-2006 62UDA08 3003001628 Shoppers Drug Mart Canada
 
AEK-7075268-4/1/1 12-Jan-2006 62VCE45 3005418439 Gard Norway
 
112-8700951-7/1/1 10-Jan-2006 62VCR42 3000126720 Hetero Drugs Limited India
 
112-8794977-9/1/1 11-Jan-2006 62VDC45 3002807200 F. Hoffmann-LaRoche Ltd. Switzerland
 
112-8717156-4/1/1 24-Jan-2006 62YCA07 3001645453 Boehringer Ingelheim Canada Canada
 
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