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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
AEK-9585679-1/1/1 02-Sep-2008 61AIK09 3007050604 Universidad De Antioquia Colombia
 
144-1813965-8/1/1 23-Sep-2008 61DKR99 3007086996 Hangzhou Xiaoshan Yongsheng Foreign Trade Co., Ltd China
 
112-4018696-8/1/5 10-Sep-2008 61EDA08 3005512930 Memphis Pharma Egypt
 
M21-0738332-7/3/1 22-Sep-2008 61FAB56 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
M21-0738332-7/6/1 22-Sep-2008 61FAE53 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
AEK-9134503-9/1/1 18-Sep-2008 61FCA54 3007115179 Dr Lall India
 
112-2382653-1/1/1 24-Sep-2008 61FCB56 3005528152 Farmacoop Colombia
 
112-4257019-3/1/1 19-Sep-2008 61FCN56 3006404285 Procaps S. A. Colombia
 
112-4157692-8/1/1 22-Sep-2008 61GCY85 3002307574 Janssen-Ortho Canada
 
M21-0738332-7/4/1 22-Sep-2008 61HAB43 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
AA8-0016692-5/18/1 19-Sep-2008 61HAL99 3005384829 Laboratorios Rangel C. Por A. Dominican Republic
 
399-0934420-0/9/2/B 17-Sep-2008 61HBJ05 3004303035 Marico Industries Limited India
 
315-8231985-6/1/1 29-Sep-2008 61JCS13 3002807978 Ranbaxy Laboratories Ltd.- Sirmour India
 
315-8231985-6/1/2 29-Sep-2008 61JCS13 3002807978 Ranbaxy Laboratories Ltd.- Sirmour India
 
315-8231985-6/1/3 29-Sep-2008 61JCS13 3002807978 Ranbaxy Laboratories Ltd.- Sirmour India
 
112-3913890-5/1/1 04-Sep-2008 61LCP29 3005753354 Sanofi Aventis United Kingdom
 
AEK-9134503-9/3/1 18-Sep-2008 61MCA99 3007115179 Dr Lall India
 
112-2232377-9/1/1 22-Sep-2008 61MCY08 3006765001 Ratiopharm Portugal
 
112-4274837-7/1/1 19-Sep-2008 61NAS32 3006005111 Aadivighnesh Chem PVT. LTD. India
 
112-4141252-0/1/1 03-Sep-2008 61NBP80 3004393730 Pfizer, Inc. United States
 
112-2167982-5/1/1 25-Sep-2008 61NCB70 3005894266 Pfizer United States
 
112-4141252-0/4/1 03-Sep-2008 61NCN65 3004207240 Egis Gyogyszertar Rt Hungary
 
112-2312758-3/1/1 24-Sep-2008 61NDA37 3000183414 Janssen Ortho Canada
 
112-4396527-7/1/1 12-Sep-2008 61NDC83 3003925187 TEVA Runcorn United Kingdom
 
112-4018696-8/1/2 10-Sep-2008 61NDE55 3005642107 Sanor Egypt
 
112-4141252-0/6/1 03-Sep-2008 61NDP76 3003712444 Glaxosmithkline Exp United Kingdom
 
AEK-9533847-7/1/5 02-Sep-2008 61PCA55 3007041622 Rose Janzen Canada
 
AEK-9533847-7/1/2 02-Sep-2008 61PCA62 3007041622 Rose Janzen Canada
 
112-4141252-0/1/3 03-Sep-2008 61PCN26 1000448661 Bristol Myers Tvl United States
 
112-4141252-0/8/1 03-Sep-2008 61PCP31 3002806761 Chemical Works of Gedeon Richter Plc., Budapest Site Hungary
 
231-7068984-1/1/2 04-Sep-2008 61PCS55 3003616352 Granules India Limited India
 
AEK-9533847-7/1/11 02-Sep-2008 61PCY54 3007041622 Rose Janzen Canada
 
XXX-0137804-2/1/2 09-Sep-2008 61PDY26 3002807008 Franco-Indian Laboratories India
 
112-4174514-3/1/1 02-Sep-2008 61TBC99 3007089332 Merck Canada
 
112-4018696-8/1/4 10-Sep-2008 61TDA12 3005408340 Eva Pharama Egypt
 
112-4350288-0/1/3 19-Sep-2008 61TDY22 3006036290 Amdipharm United Kingdom
 
112-4140891-6/1/1 19-Sep-2008 61WBO18 3003199814 Engelhard Arzneimittel Germany
 
ALN-5504553-6/1/1 22-Sep-2008 61WCS45 3003339630 Cipla Limited India
 
112-4018696-8/1/9 10-Sep-2008 61XDA09 3005439604 Janssen-Cilag Egypt
 
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