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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
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AV3-0023235-0/2/15 31-Jan-2011 60CBL49 2244859 Novartis Consumer Health Inc. United States
 
AV3-0023235-0/2/16 31-Jan-2011 60CBL49 2244859 Novartis Consumer Health Inc. United States
 
112-7002580-5/1/2 05-Jan-2011 60DIY99 3007486356 Francisco R Nunez Dominican Republic
 
112-5127542-0/1/1 07-Jan-2011 60GAA01 3008022633 Ozyone India
 
112-7237615-6/1/1 04-Jan-2011 60LAY01 3007505524 Malviya Chemicals & Pharmaceutic India
 
112-6715860-1/1/1 06-Jan-2011 60LBA05 3003712444 Glaxosmithkline Exp United Kingdom
 
112-6715860-1/1/2 06-Jan-2011 60LBA05 3003712444 Glaxosmithkline Exp United Kingdom
 
112-6715860-1/1/3 06-Jan-2011 60LBA05 3006649971 Wyeth Research Ltd United Kingdom
 
112-6706047-6/1/1 06-Jan-2011 60LBA99 3005828478 Glaxosmithkline New Zealand
 
AM1-0169992-5/1/1 07-Jan-2011 60LBI01 2210776 Novartis Pharmaceutical Comp. United States
 
AM1-0169992-5/1/3 07-Jan-2011 60LBI01 2210776 Novartis Pharmaceutical Comp. United States
 
H77-0124176-9/16/2 05-Jan-2011 60LBJ99 3005162154 Rangoon Chemical Works, PVT. LTD. India
 
KG2-0527460-1/1/7 26-Jan-2011 60LBL01 2210396 Novartis Pharmaceuticals Corp. United States
 
KG2-0527460-1/1/10 26-Jan-2011 60LBL01 2210396 Novartis Pharmaceuticals Corp. United States
 
KG2-0527460-1/1/13 26-Jan-2011 60LBL01 2210396 Novartis Pharmaceuticals Corp. United States
 
AEK-8602342-7/1/1 24-Jan-2011 60LBO99 3008713512 Farmacias De Ahorro Honduras
 
AEK-8358985-9/1/1 07-Jan-2011 60LCA01 3008562907 Fahul Karim Bangladesh
 
M21-0742784-3/1/1 07-Jan-2011 60LCA01 3005144955 Chemo S.A. Lugano Branch Switzerland
 
UPS-0666206-4/1/2 06-Jan-2011 60LCA14 3008676098 Mr. Pratik Chadha India
 
AEK-8360964-0/2/1 06-Jan-2011 60LCA99 3008596148 Sd Sawheny India
 
AEK-8578468-0/4/1 12-Jan-2011 60LCY01 3006759484 Mcneil Products United Kingdom
 
XXX-0272029-1/1/2 10-Jan-2011 60LCY21 3006406738 Sinochem Ningbo Ltd China
 
AEK-8626179-5/1/2 12-Jan-2011 60LDA01 3008726214 Jagannail Singh India
 
112-7378532-2/3/4 04-Jan-2011 60LDE04 3007532922 Relaxpharmaceuticals India
 
112-6587546-1/2/2 06-Jan-2011 60LDO05 3003023771 Roche Pharmaceuticals Canada
 
XXX-0270775-1/1/7 03-Jan-2011 60LDY99 3005203073 Bayer S.A. Guatemala
 
101-8707276-3/1/1 19-Jan-2011 60NCS10 3004459466 Yicheng Goto Pharmaceuticals Co., Ltd China
 
112-0323233-0/1/1 18-Jan-2011 60PCC03 3008702486 Roche Inc Philippines
 
112-7891174-1/1/1 03-Jan-2011 60QBO86 3002829763 Astra Zeneca Canada
 
XXX-0270775-1/1/10 03-Jan-2011 60QBY40 3007730186 lABORATORIOS SANTE, S.A. Guatemala
 
XXX-0199118-2/1/1 12-Jan-2011 60QDY46 3007237085 JAMES BROWN PHARMA Ecuador
 
AEK-8366788-7/1/1 31-Jan-2011 60QIB60 3008732603 Mrugesh Khimasia India
 
112-7843014-8/1/1 03-Jan-2011 60QIY15 3003751772 Medical Developements Australia
 
300-3649348-2/40/1 07-Jan-2011 60SAZ99 3004512975 Southern Drugs & Pharmaceuticals India
 
300-3859750-4/15/1 10-Jan-2011 60SAZ99 3004512975 Southern Drugs & Pharmaceuticals India
 
300-3859750-4/14/1 10-Jan-2011 60SAZ99 3004512975 Southern Drugs & Pharmaceuticals India
 
112-7594340-8/3/1 04-Jan-2011 60SBA04 3003899848 Unilab Philippines
 
AM1-0169992-5/1/13 07-Jan-2011 60SBA04 2244859 Novartis Consumer Health Inc. United States
 
AM1-0169992-5/1/14 07-Jan-2011 60SBA04 2244859 Novartis Consumer Health Inc. United States
 
112-0014856-2/2/1 06-Jan-2011 60SBA99 3000130652 Naturally Nova Scotia Health Canada
 
AV3-0023235-0/2/25 31-Jan-2011 60SBL04 2244859 Novartis Consumer Health Inc. United States
 
AV3-0023235-0/2/26 31-Jan-2011 60SBL04 2244859 Novartis Consumer Health Inc. United States
 
AV3-0023235-0/2/27 31-Jan-2011 60SBL04 2244859 Novartis Consumer Health Inc. United States
 
AV3-0023235-0/2/28 31-Jan-2011 60SBL04 2244859 Novartis Consumer Health Inc. United States
 
112-6522511-3/1/1 06-Jan-2011 60SCL07 3007378453 S M F France
 
112-5220018-7/2/1 06-Jan-2011 60SDB07 3007218033 Sanofi Aventis Colombia
 
112-5164943-4/1/1 07-Jan-2011 60TIS99 3002807868 Pfizer, Ltd. United Kingdom
 
XXX-0272029-1/1/6 10-Jan-2011 60WCY01 3004164102 Glaxo Smith Kline Mexico Mexico
 
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