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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
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-6147658-7/3/1 30-Jul-2009 62CCB38 3002906944 Apotex Inc. Canada
 
AEK-9796773-7/1/1 01-Jul-2009 62FLQ34 3007545607 Teijin Chemicals Ltd Japan
 
M21-0739992-7/1/1 06-Jul-2009 62GBA41 3006497359 Research Pharmaceutical Colombia
 
N56-0017117-1/2/1/A 10-Jul-2009 62GBJ99 3005645174 Clique Exports Pvt India
 
N56-0017117-1/2/1/B 10-Jul-2009 62GBJ99 3005645174 Clique Exports Pvt India
 
N56-0017117-1/2/1/C 10-Jul-2009 62GBJ99 3005645174 Clique Exports Pvt India
 
112-5540933-9/3/2 29-Jul-2009 62GCA49 3005690785 Mcneil Gmbh & Co United Kingdom
 
GR6-5207372-1/1/1 08-Jul-2009 62GSY90 3007380440 Norvartis International Pharmaceuticals Ltd. Ireland
 
GR6-5207372-1/2/1 08-Jul-2009 62GSY90 3007380440 Norvartis International Pharmaceuticals Ltd. Ireland
 
GR6-5207372-1/3/1 08-Jul-2009 62GSY90 3007380440 Norvartis International Pharmaceuticals Ltd. Ireland
 
112-6114952-3/1/1 31-Jul-2009 62ICB99 3007317317 Burzynski Clinic United States
 
AM4-0191624-3/2/9 23-Jul-2009 62MAA08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
XXX-0162599-6/2/8 08-Jul-2009 62MBJ08 3007566202 Laboratorio Trinidad Guatemala
 
XXX-0162599-6/2/9 08-Jul-2009 62MBO08 3007566218 GlaxoSmithkline Costa Rica
 
HA9-0900043-2/20/1 01-Jul-2009 62MBY08 3004856210 Lankan Delight Sri Lanka
 
112-6057381-4/1/1 31-Jul-2009 62OAY17 3003228982 Alcon Canada Inc Canada
 
M21-0740127-7/1/1 06-Jul-2009 62OCA14 3007680821 Ms. J P N Pharma Pvt Ltd India
 
M21-0740027-9/1/1 08-Jul-2009 62OCA28 3006094247 Research Pharmaceutical Co Ltd China
 
112-7898062-1/2/1 22-Jul-2009 62VCA34 3002806556 Boehringer Ingelheim Pharma GmbH & Co. KG Germany
 
AEK-9822018-5/1/3 06-Jul-2009 62VCA45 3007607843 Laboratories Coloplast France
 
AEK-9822018-5/1/1 06-Jul-2009 62VCA99 3007607843 Laboratories Coloplast France
 
WTV-0018224-9/1/1 23-Jul-2009 62VCH45 3007022409 Roche Registration Limited United Kingdom
 
UPS-5375426-1/8/3/A 15-Jul-2009 62VCJ18 3005367847 Bayer United Kingdom
 
UPS-5023731-0/2/1 08-Jul-2009 62VCY45 3003247644 Roche Diagnostics Gmbh Germany
 
XXX-0255924-4/1/1 16-Jul-2009 62VDB15 3006137141 Cipla Ltd India
 
112-7898062-1/1/1 16-Jul-2009 62VDE17 3003262904 Glaxo Operations UK Limited United Kingdom
 
112-6301036-8/3/1 31-Jul-2009 62VDJ18 3007338349 Healthy Pharm Argentina
 
AEK-9897480-7/5/1 17-Jul-2009 62WBL99 3006672609 Easy Parapharmacie France
 
EBH-0064332-3/36/1/A 22-Jul-2009 62WBU17 3003995293 Sara Lee Philippines, Inc. Philippines
 
EBH-0064332-3/36/1/B 22-Jul-2009 62WBU17 3003995293 Sara Lee Philippines, Inc. Philippines
 
EBH-0064332-3/36/1/C 22-Jul-2009 62WBU17 3003995293 Sara Lee Philippines, Inc. Philippines
 
EBH-0064332-3/36/1/D 22-Jul-2009 62WBU17 3003995293 Sara Lee Philippines, Inc. Philippines
 
EBH-0064332-3/36/1/E 22-Jul-2009 62WBU17 3003995293 Sara Lee Philippines, Inc. Philippines
 
EBH-0064332-3/36/1/F 22-Jul-2009 62WBU17 3003995293 Sara Lee Philippines, Inc. Philippines
 
277-0122240-1/20/1 30-Jul-2009 62WBY09 3007141766 Sahaphant Co.,Ltd Thailand
 
M34-6602467-6/1/1 01-Jul-2009 62ZCS08 3002806695 Cilag AG Switzerland
 
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