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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
XXX-0128832-4/1/3 11-Oct-2005 63BCQ25 3000826783 Glaxo Wellcome France
 
112-8397086-1/1/1 25-Oct-2005 63BCS27 3004111937 Indo Gulf Trading Company India
 
AEK-6822032-2/3/1 05-Oct-2005 63BDQ01 3005318802 Beena Thomas India
 
110-2359466-0/1/1 19-Oct-2005 63ECB13 3005354105 Actavis (previously Alpharma Limited) United Kingdom
 
XXX-0126906-8/1/6 11-Oct-2005 63EDC19 3003279122 Sanofi Synthelabo De Colombia S.A. Colombia
 
F30-0040391-3/4/1 06-Oct-2005 63HCI08 3002650191 T.G. Import Export Trading Company Limited Jamaica
 
115-0052341-7/8/1 06-Oct-2005 63RBL04 3005172271 Households & Tolietires Manufacturi Jordan
 
W69-1234344-0/9/1 15-Oct-2005 63RBY04 3003884046 Shanghai Whitecat Shareholding Co., Ltd. China
 
W69-1234344-0/9/2 15-Oct-2005 63RBY04 3003884046 Shanghai Whitecat Shareholding Co., Ltd. China
 
W69-1232476-2/6/1 15-Oct-2005 63RBY04 3003884046 Shanghai Whitecat Shareholding Co., Ltd. China
 
W69-1232476-2/6/2 15-Oct-2005 63RBY04 3003884046 Shanghai Whitecat Shareholding Co., Ltd. China
 
W69-1237595-4/8/1 15-Oct-2005 63RBY04 3003884046 Shanghai Whitecat Shareholding Co., Ltd. China
 
W69-1237595-4/8/2 15-Oct-2005 63RBY04 3003884046 Shanghai Whitecat Shareholding Co., Ltd. China
 
W69-1221400-5/3/1 19-Oct-2005 63RBY04 3003884046 Shanghai Whitecat Shareholding Co., Ltd. China
 
W69-1221400-5/3/2 19-Oct-2005 63RBY04 3003884046 Shanghai Whitecat Shareholding Co., Ltd. China
 
W69-1221400-5/3/3 19-Oct-2005 63RBY04 3003884046 Shanghai Whitecat Shareholding Co., Ltd. China
 
ABX-1000970-0/20/1 05-Oct-2005 63RBY05 3003268976 Dong A Pharmaceutical Co.,Ltd. Korea, Republic Of (South)
 
ABX-1000970-0/20/2 05-Oct-2005 63RBY05 3003268976 Dong A Pharmaceutical Co.,Ltd. Korea, Republic Of (South)
 
AYG-1000602-6/51/1 21-Oct-2005 63RBY99 3005315413 Advanced Oral Care Products Pvt., Ltd India
 
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