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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
112-8512160-4/1/1 25-Oct-2005 61ECB08 3004010466 Essex Pharma Germany
112-8504072-1/3/1 03-Oct-2005 61ECY99 3001295878 Astra Pharmaceuticals Philippines
112-8512160-4/2/1 25-Oct-2005 61ECZ04 3004514528 Astra Zeneca Gmbh Germany
112-8604382-3/4/1 21-Oct-2005 61EDK14 3005355197 Exelvision Annonay France
XXX-0129503-0/1/2 19-Oct-2005 61EDQ04 3003979051 Astra Zeneca Switzerland
XXX-0128832-4/1/4 11-Oct-2005 61EDQ11 3000826783 Glaxo Wellcome France
112-8442615-2/1/11 24-Oct-2005 61EDY11 3005328139 Glaxo Smith Kline Turkey
112-8492115-2/2/3 11-Oct-2005 61FBH56 3005334724 Farmacoop Colombia
AYG-1000525-9/18/1 26-Oct-2005 61FBL21 3004272360 Unique Fragrances India
AYG-1000525-9/19/1 26-Oct-2005 61FBL21 3004272360 Unique Fragrances India
112-8715973-5/1/2 21-Oct-2005 61FCA55 3005368240 Elmor Sa Venezuela
XXX-0128832-4/1/6 11-Oct-2005 61FDJ52 3003236116 LABORTOIRES GALDERMA France
XXX-0128832-4/1/5 11-Oct-2005 61FDL52 3003236116 LABORTOIRES GALDERMA France
110-2128964-4/1/1 11-Oct-2005 61FIY55 3005331937 Wexford Laboratories Pvt Ltd India
XXX-0129144-3/1/7 11-Oct-2005 61GDB04 3003279122 Sanofi Synthelabo De Colombia S.A. Colombia
XXX-0129144-3/1/4 11-Oct-2005 61GDL57 3004175446 Ruipharma , S.A. Guatemala
112-8394782-8/1/1 03-Oct-2005 61HBL99 3003198686 Vivier Pharma, Inc. Canada
115-0052341-7/4/1 06-Oct-2005 61HBY99 3005172271 Households & Tolietires Manufacturi Jordan
112-8581581-7/1/1 24-Oct-2005 61HIL99 1000522077 Packaging Coordinators, Inc. United States
WRE-0332669-1/20/1 18-Oct-2005 61JAY99 3001614433 Shantou Suntop Footwear Co. Ltd. China
112-8667016-1/1/1 21-Oct-2005 61JCA10 3001059001 Novartis International Ag Switzerland
AEK-6822118-9/1/3 05-Oct-2005 61JCC14 3005318986 Savon Pharmacy United States
112-8426719-2/1/1 24-Oct-2005 61JCY01 3004530491 Neopharm Ltd Israel
112-8442615-2/1/3 24-Oct-2005 61JCY08 3005328141 Pfizer Turkey
AEK-6680158-6/1/2 29-Oct-2005 61JDA11 3005325985 Alan Malapan Philippines
AEK-7063845-3/2/2 31-Oct-2005 61LCE99 3005313676 Methodos S Pa Italy
AEK-7063845-3/2/3 31-Oct-2005 61LCE99 3005313676 Methodos S Pa Italy
XXX-0126906-8/1/5 11-Oct-2005 61LDB13 3004527544 Laboratorios Farmaceuticos Colombia
AEK-6822032-2/2/1 05-Oct-2005 61MBA30 3005318802 Beena Thomas India
112-8496281-8/1/1 25-Oct-2005 61NCB32 3003447843 Novartis De Colombia S.A. Colombia
112-8545305-6/2/1 24-Oct-2005 61NCP65 3004562359 Biotech Laboratories Venezuela
112-8528463-4/1/1 24-Oct-2005 61NCP99 1000656034 Eli Lilly And Company Limited United Kingdom
AEK-6678863-5/1/2 04-Oct-2005 61NDA65 3005304798 Pd Black United Kingdom
XXX-0126423-4/1/1/D 11-Oct-2005 61NDA73 3004632970 Organon Venezuela
112-8325146-0/1/1 21-Oct-2005 61NDA99 3005312066 Laboratorie Chile Chile
XXX-0129143-5/1/3 11-Oct-2005 61NDC55 3004252020 Abbott SpA Italy
XXX-0129143-5/1/2 11-Oct-2005 61NDC65 3004175007 H. Lundbeck A/S Denmark
AEK-7553497-0/1/1 04-Oct-2005 61NDZ82 3004021983 Galen Ltd Bulgaria
AEK-6822118-9/1/5 05-Oct-2005 61PCC55 3005318986 Savon Pharmacy United States
112-8426719-2/2/1 24-Oct-2005 61PCY26 3004734229 Cid Egypt
XXX-0128595-7/1/1 11-Oct-2005 61PCY31 3003641053 Aventis Pharma SA Guatemala
112-8426719-2/3/1 24-Oct-2005 61PCY31 3004448945 Aventis Pharma Ltd India
112-8847801-9/1/1 24-Oct-2005 61PCY61 3005385637 Miceli Jose Luis Argentina
AEK-6680158-6/2/1 29-Oct-2005 61PDA09 3005325985 Alan Malapan Philippines
112-8299587-7/4/1 04-Oct-2005 61PDA55 1000544186 IVAX Research, Inc. United States
XXX-0128831-6/1/1 11-Oct-2005 61PDC26 3004971395 Quimica Montpellier S.A. Argentina
XXX-0128831-6/1/2 11-Oct-2005 61PDC26 3005140572 Craveri Saic Argentina
XXX-0128831-6/1/3 11-Oct-2005 61PDC62 3003182177 Laboratories Phoenix S.A.I.C.F. Argentina
XXX-0128595-7/1/2 11-Oct-2005 61PDY55 1000203918 Merck Sharp & Dohme Mexico Mexico
112-8442615-2/1/1 24-Oct-2005 61PDY61 3005328139 Glaxo Smith Kline Turkey
112-8494949-2/1/1 25-Oct-2005 61RBY11 3002628529 Pharmascience Inc. Canada
DO7-0097313-7/1/1 14-Oct-2005 61VBL99 3005293463 Mateur Cameroon
XXX-0128087-5/1/2 11-Oct-2005 61VDC01 3005312743 ivax Argentina
AYG-1000512-7/34/1 27-Oct-2005 61WBE99 3004259394 The Himalaya Drug Company India
112-8512277-6/1/2 25-Oct-2005 61WCA52 3005337453 Laboratorio Sued S.A Dominican Republic
XXX-0128380-4/1/1 11-Oct-2005 61WCF45 1000281220 Corporacion Bonimas Sa El Salvador
112-8512277-6/1/1 25-Oct-2005 61WCL52 3005337453 Laboratorio Sued S.A Dominican Republic
112-8545305-6/4/1 24-Oct-2005 61WCP03 3004115501 Aventis Pharma Deutschl Germany
112-8366784-8/1/1 25-Oct-2005 61WCY03 3004537221 Bayer Americas Colombia
112-8442615-2/1/6 24-Oct-2005 61WCY52 3005328140 Novartis Turkey
XXX-0128570-0/1/5 11-Oct-2005 61WDA45 1110315 Mylan Pharmaceuticals Inc. United States
XXX-0128570-0/1/8 11-Oct-2005 61WDJ52 3003339540 Unipharm S.A Guatemala
112-8492115-2/2/1 11-Oct-2005 61XBY45 3005334724 Farmacoop Colombia
112-7909502-9/1/1 26-Oct-2005 61XCP99 1000476214 Mead Johnson De Mexico/Bristol Myers de Mexico S.A. de C.V. Mexico
XXX-0128609-6/1/2 11-Oct-2005 61XDC09 3004566963 Pharmakon S.A. Division Brijan Guatemala
XXX-0129144-3/1/6 11-Oct-2005 61XDC09 3005321232 Ingrid Vasquez Guatemala