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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
112-6368536-8/1/1 08-Jun-2011 63BDQ25 3003262904 Glaxo Operations UK Limited United Kingdom
 
112-6368536-8/1/4 08-Jun-2011 63BDQ25 3003262904 Glaxo Operations UK Limited United Kingdom
 
112-6368536-8/1/3 08-Jun-2011 63BDQ25 3003262904 Glaxo Operations UK Limited United Kingdom
 
112-6368536-8/1/2 08-Jun-2011 63BDQ25 3003262904 Glaxo Operations UK Limited United Kingdom
 
EH2-0015417-5/1/1 03-Jun-2011 63EDA13 3008616935 Pharmaceutical Company Zdorv'E Ltd Ukraine
 
XXX-0174022-5/1/3 30-Jun-2011 63HDY12 3003893366 Laboratorios La Sante Colombia
 
XXX-0174022-5/1/5 30-Jun-2011 63HDY24 3007730186 lABORATORIOS SANTE, S.A. Guatemala
 
BWR-0044885-8/1/1 10-Jun-2011 63NCY08 3003218981 Dolder AG Switzerland
 
KM6-0052234-6/7/2 23-Jun-2011 63RAJ05 3004488639 ALA Chemicals Pakistan
 
BMW-0028597-7/2/1 10-Jun-2011 63RAL04 3008283089 Hin Sang Hong Company Ltd Hong Kong SAR
 
AJN-0076936-6/4/1 15-Jun-2011 63RAY04 3001119986 Mission Hills, S.A. de C.V. Mexico
 
AJN-0076940-8/1/1 15-Jun-2011 63RAY04 3001119986 Mission Hills, S.A. de C.V. Mexico
 
AJN-0076955-6/4/1 15-Jun-2011 63RAY04 3007198939 Colgate Palmolive Mexico
 
AJN-0076938-2/1/1 29-Jun-2011 63RAY04 3001119986 Mission Hills, S.A. de C.V. Mexico
 
AJN-0076953-1/3/1 29-Jun-2011 63RAY04 3001119986 Mission Hills, S.A. de C.V. Mexico
 
AJN-0077062-0/8/1 29-Jun-2011 63RAY04 3007198939 Colgate Palmolive Mexico
 
KM6-0052234-6/7/1 23-Jun-2011 63RBJ05 3008502338 Medicam Laboratories Dental Care Division Pakistan
 
AEK-8754561-8/1/1/B 23-Jun-2011 63XCY99 3008902822 Kundan Kidney Care Centre India
 
AEK-8754561-8/1/1/C 23-Jun-2011 63XCY99 3008902822 Kundan Kidney Care Centre India
 
AEK-8754561-8/1/1/D 23-Jun-2011 63XCY99 3008902822 Kundan Kidney Care Centre India
 
AEK-8754561-8/1/1/E 23-Jun-2011 63XCY99 3008902822 Kundan Kidney Care Centre India
 
AEK-8775347-7/1/1 28-Jun-2011 63XCY99 3008967579 Krishna Swamy India
 
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