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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 63-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-9791962-7/1/1 07-Jun-2012 63AIB99 3004010606 Matrix Laboratories Ltd India
 
112-8168146-4/1/1/A 01-Jun-2012 63ALZ10 3003222551 Ceva Sante Animale France
 
112-6871083-1/1/1 20-Jun-2012 63BAL25 1035048 GlaxoSmithKline United States
 
112-6853869-5/1/1 18-Jun-2012 63BCQ25 3007020424 Angiodynamics Uk Ltd United Kingdom
 
112-6853869-5/1/3 18-Jun-2012 63BCQ25 3007020424 Angiodynamics Uk Ltd United Kingdom
 
112-6853869-5/1/2 18-Jun-2012 63BCQ25 3007020424 Angiodynamics Uk Ltd United Kingdom
 
XXX-0286383-6/1/5 12-Jun-2012 63BCQ26 3005659087 Boehringer Ingelheim Ltd. United Kingdom
 
112-6134498-5/1/1 19-Jun-2012 63ECA13 3003575424 Astra Zeneca United Kingdom
 
112-6134498-5/2/1 19-Jun-2012 63ECA13 3005072567 Apotex Inc. Canada
 
112-2514026-3/1/1 04-Jun-2012 63EDA13 2518137 AstraZeneca Pharmaceuticals LP United States
 
112-7088633-0/1/1 08-Jun-2012 63HCZ10 3003067904 Solvay Pharmaceuticals S. A. Spain
 
WRT-0142405-2/1/1 01-Jun-2012 63JAL17 3001956890 Assured Packaging Inc. Canada
 
WRT-0141989-6/1/1 01-Jun-2012 63JBL17 3001956890 Assured Packaging Inc. Canada
 
112-7500186-0/1/1/B 29-Jun-2012 63NCA25 3005886410 Minapharm Pharmaceuticals Egypt
 
KM6-0122130-2/12/1 11-Jun-2012 63RAO05 3008459891 Pankaj Exports India
 
KM6-0122130-2/12/7 11-Jun-2012 63RAO05 3008459891 Pankaj Exports India
 
KM6-0057195-4/12/2 20-Jun-2012 63RAY05 3008468427 Wf Limited India
 
KM6-0056645-9/15/2 26-Jun-2012 63RBW06 3008468427 Wf Limited India
 
109-0855435-4/1/1 08-Jun-2012 63RBY06 3008454944 Colgate Palmolive United Arab Emirates
 
112-6605359-9/2/1/D 19-Jun-2012 63RBY06 3007952912 Glaxosmithkline Consumer Healthcare Gmbh & Co Kg Germany
 
112-6605359-9/2/1/E 19-Jun-2012 63RCY06 3003177254 Dr. Theiss Naturwaren Gmbh Germany
 
112-6605359-9/2/1/F 19-Jun-2012 63RCY06 3006118127 Gaba Gmbh Germany
 
112-6795847-3/1/1 13-Jun-2012 63XIP99 3002807756 Teva Canada Limited Canada
 
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