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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
112-9192877-1/1/1 06-Nov-2009 61ECK11 3007355139 Cipla Ltd India
 
112-5660799-8/2/1 05-Nov-2009 61FCA54 2243252 Bayer HealthCare Pharmaceuticals Inc. United States
 
112-6115906-8/2/1 02-Nov-2009 61FCJ42 3004309672 Cardinal Healthcare Argentina
 
K51-0067415-6/5/1 02-Nov-2009 61HBU99 3003019111 Colgate-Palmolive Co. Dominica
 
112-5874146-4/1/1 02-Nov-2009 61HCB99 3007621329 Zydus BSV Pharma Private Limited India
 
823-0133984-0/15/1/B 13-Nov-2009 61HMK03 3001221787 Laboratorios Real, S.A. de C.V. El Salvador
 
112-5664151-8/2/1 02-Nov-2009 61JCA09 3002653619 Fournier Pharma Inc Canada
 
112-5664151-8/1/1 02-Nov-2009 61LDA38 3005176444 Bristol-Myers United States
 
112-5343007-1/1/1 03-Nov-2009 61MDC40 3006417191 Janssen-Cilag Ltd United Kingdom
 
112-9333196-6/1/1 05-Nov-2009 61NCC29 3004518982 Lilly Egypt Sae Egypt
 
655-1481897-4/1/1 10-Nov-2009 61NCS69 3002691261 Teva Assia Chemical Ind Ltd Israel
 
655-1481897-4/2/1 10-Nov-2009 61NCS69 3002691261 Teva Assia Chemical Ind Ltd Israel
 
655-1481897-4/3/1 10-Nov-2009 61NCS69 3002691261 Teva Assia Chemical Ind Ltd Israel
 
112-9072183-9/1/1 06-Nov-2009 61PCA55 3005799877 Hexal Spa Italy
 
112-9379938-6/1/5 12-Nov-2009 61TCA27 3007894961 Cipla Ltd India
 
112-5874146-4/7/1 02-Nov-2009 61TCB99 3005181323 Polipharm Co. , Ltd. Thailand
 
112-6216323-4/1/1 02-Nov-2009 61UDA05 3002806880 Egis PLC Hungary
 
K51-0067415-6/8/1 02-Nov-2009 61VAL99 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
XXX-0168998-4/2/1 12-Nov-2009 61VBL99 3007934757 Bio Organic Plus Philippines
 
112-5874146-4/5/1 02-Nov-2009 61WCB45 3003480352 Taro Pharmaceutical Industries Ltd Israel
 
112-5874146-4/4/1 02-Nov-2009 61WCB45 3007287406 Lab Wah Medical Chile
 
112-6115906-8/1/1 02-Nov-2009 61WCE45 3004043379 Novartis Austria
 
334-2761257-8/2/1 17-Nov-2009 61XAS08 3007309614 Malladi Drugs & Pharmaceuticals Ltd India
 
112-9697190-9/1/1 23-Nov-2009 61XAS37 3007939093 Pharma Rx Chemical Corporation India
 
112-9383733-5/1/1 03-Nov-2009 61XBB08 3003712444 Glaxosmithkline Exp United Kingdom
 
112-9379938-6/1/6 12-Nov-2009 61XCA45 3007894962 Emcure Pharmaceuticals India
 
112-9874024-5/1/1 24-Nov-2009 61XCS99 3004109039 Glenmark Pharmaceuticals Ltd India
 
112-9379938-6/1/10 12-Nov-2009 61XDK08 3007894963 Himalaya Drugs Company India
 
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