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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 62-Human and Animal Drugs

Entry/doc/line/sfx Refusal Date Product
AEK-9622894-1/1/1 25-Oct-2010 62CCY99 3008505081 Dalbert Internacional Sa Venezuela
M21-0742196-0/1/1 18-Oct-2010 62FAA34 3006094247 Research Pharmaceutical Co Ltd China
820-4505181-8/11/1 15-Oct-2010 62FAK20 3008378789 Fitofarm Ukraine
BJV-0231311-3/1/1 27-Oct-2010 62FBJ23 2411192 Professional Disposables International, Inc. United States
BJV-0231311-3/1/2 27-Oct-2010 62FBJ23 2411192 Professional Disposables International, Inc. United States
185-0055129-8/29/1 06-Oct-2010 62FDJ99 3006039460 Vicco laboratories India
M21-0742524-3/1/1 26-Oct-2010 62GBA41 3006623417 Granules India Limited India
112-7777571-7/1/1 25-Oct-2010 62GDB18 3003699941 Cipla Ltd India
112-8907573-4/1/1 07-Oct-2010 62GDY53 3007774728 Zanagen Ltd Canada
112-8907717-7/1/1 06-Oct-2010 62HBJ99 3007808989 Innovative Cosmetics Israel
814-0179639-6/1/1 19-Oct-2010 62HBL99 3006528506 Hangzhou Karic Commodities Co.Ltd China
M21-0742480-8/1/1 20-Oct-2010 62KAE10 3008367099 Shanghai Trifecta Pharma Ltd. China
112-8510248-3/8/1 25-Oct-2010 62KBC10 3006595385 Cadila Healthcare Limited India (Zyfine) India
FY6-2007887-0/20/1 04-Oct-2010 62MAJ08 3004135577 Novartis United States
820-4506208-8/11/1/A 13-Oct-2010 62MBJ01 3008419088 Ooo Iq Cosmetic Russia
820-4506208-8/11/1/B 13-Oct-2010 62MBJ08 3008419088 Ooo Iq Cosmetic Russia
820-4506208-8/9/1 13-Oct-2010 62MBL08 3008419088 Ooo Iq Cosmetic Russia
112-8511940-3/2/1 05-Oct-2010 62OAB18 1000289508 Braco Spa Italy
112-8510248-3/7/1 25-Oct-2010 62OBB14 3003047405 Pfizer Ireland Pharmaceuticals Ireland
112-8510248-3/1/1 25-Oct-2010 62OBB29 3007036455 Health 2000 Inc Canada
112-9233179-4/2/1 19-Oct-2010 62OCC14 3001203985 Pfizer Canada Inc. - Kirkland, QC Administrative Site Canada
112-7777571-7/2/2 25-Oct-2010 62ODB05 3002807186 Valeant Pharmaceuticals International Inc. Canada
APF-0008426-7/1/1 28-Oct-2010 62UAY99 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico