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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
D52-0892245-5/8/1 07-Jan-2004 61FBK21 3003826208 Reckitt Benckiser (India) Limited India
 
D52-0892245-5/8/2 07-Jan-2004 61FBK21 3003826208 Reckitt Benckiser (India) Limited India
 
D52-0892245-5/8/3 07-Jan-2004 61FBK21 3003826208 Reckitt Benckiser (India) Limited India
 
XXX-0074825-2/1/1 05-Jan-2004 61FLP21 3003452796 Reckitt Benckiser India
 
315-6167676-3/1/1 22-Jan-2004 61JDA13 3008612636 Pliva Croatia Croatia
 
315-6167676-3/1/2 22-Jan-2004 61JDA13 3008612636 Pliva Croatia Croatia
 
315-6167676-3/1/3 22-Jan-2004 61JDA13 3008612636 Pliva Croatia Croatia
 
315-6167676-3/1/4 22-Jan-2004 61JDA13 3008612636 Pliva Croatia Croatia
 
315-6167676-3/1/5 22-Jan-2004 61JDA13 3008612636 Pliva Croatia Croatia
 
315-6167676-3/1/6 22-Jan-2004 61JDA13 3008612636 Pliva Croatia Croatia
 
112-2363166-4/1/1 30-Jan-2004 61JDB99 3003575424 Astra Zeneca United Kingdom
 
396-0132341-1/1/1 23-Jan-2004 61LCA38 3003053630 Miller & Miller Chemical Ltd United Kingdom
 
112-2276582-8/1/1 30-Jan-2004 61MIP06 3004368800 Am Enterprises Pakistan
 
AEK-6949903-2/1/1 27-Jan-2004 61NCA32 3004411525 Menonnite Israel
 
AEK-6949905-7/1/1 27-Jan-2004 61NCA32 3004411525 Menonnite Israel
 
AEK-6949904-0/1/1 27-Jan-2004 61NCA32 3004411525 Menonnite Israel
 
112-2271183-0/1/1 06-Jan-2004 61NDH78 3001203985 Pfizer Canada Inc. - Kirkland, QC Administrative Site Canada
 
112-2253772-2/1/1 05-Jan-2004 61NDY99 3002807086 GlaxoSmithKline Inc. Canada
 
112-2253772-2/1/2 05-Jan-2004 61NDY99 3002807086 GlaxoSmithKline Inc. Canada
 
112-2253772-2/1/3 05-Jan-2004 61NDY99 3001203985 Pfizer Canada Inc. - Kirkland, QC Administrative Site Canada
 
112-2253772-2/1/4 05-Jan-2004 61NDY99 3002807756 Teva Canada Limited Canada
 
112-2253772-2/1/5 05-Jan-2004 61NDY99 3002645754 Apotex Canada Inc. Canada
 
112-2253772-2/1/6 05-Jan-2004 61NDY99 3002807756 Teva Canada Limited Canada
 
112-2253772-2/1/7 05-Jan-2004 61NDY99 3002807756 Teva Canada Limited Canada
 
112-2253772-2/1/8 05-Jan-2004 61NDY99 3002807756 Teva Canada Limited Canada
 
AEK-6946022-4/7/1 20-Jan-2004 61PCB55 3004364910 Sumit Kapoor India
 
AEK-6946022-4/1/1 20-Jan-2004 61PCK17 3004364910 Sumit Kapoor India
 
112-2137504-1/1/1 09-Jan-2004 61PDB55 3004115501 Aventis Pharma Deutschl Germany
 
J37-0004173-7/8/1 08-Jan-2004 61WBK99 3003991676 Fito Peru Export Import Sac Peru
 
112-2216928-6/2/1 29-Jan-2004 61XCP99 3004360431 Pharmacie Lekbira Morocco
 
ATH-1001030-9/11/1/A 21-Jan-2004 61XDL14 3003890491 Medor Elisabeth Sildor Haiti
 
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