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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 60-Human and Animal Drugs

Entry/doc/line/sfx Refusal Date Product
112-0742519-3/1/1 17-Sep-2008 60CAK53 3003293280 Novatis Canada
EB5-0041072-6/4/1 24-Sep-2008 60CCS22 3004136167 Hangzhou FST Pharmaceutical Company Ltd China
112-4272209-1/1/1 19-Sep-2008 60IDB01 3004943406 Pharma 2000 Pte Ltd Singapore
112-4312846-2/1/1 19-Sep-2008 60LAB05 3004537450 Wyeth Consumer Hea Canada
K74-0148185-1/8/1/B 22-Sep-2008 60LAL01 3005583930 Bristol Myers Squibb France
K74-0148185-1/8/1/C 22-Sep-2008 60LAL01 3005583930 Bristol Myers Squibb France
AEK-9533847-7/1/6 02-Sep-2008 60LCA05 3007041622 Rose Janzen Canada
112-4116154-9/1/1 19-Sep-2008 60LDA89 3005524593 Glaxosmithkline Biologicals Canada
DO7-8203920-3/1/1 29-Sep-2008 60LDQ99 3007103593 Glaxosmithkline A.S. Norway
112-3884338-0/1/1 03-Sep-2008 60RCE99 3002806462 Bayer Pharma AG Germany
UPS-2200580-3/1/1 19-Sep-2008 60SIN99 3007094155 Lorenzo Caporal Golpe Mexico
AEK-9564217-5/1/1 24-Sep-2008 60WCA16 3006585379 Micro Labs Limited India
112-2232377-9/2/2 22-Sep-2008 60WCY01 3005512963 Ens Industria Farmaceutica Ltda Brazil
AEK-9131263-3/3/2 19-Sep-2008 60XCB17 3007083495 Gautam Magrath India