• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

Refusal Actions by FDA as Recorded in OASIS

for 61-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
906-1055842-2/1/1 10-Dec-2010 61ACS08 3004257189 G. Amphray Laboratories India
 
112-0222672-1/2/1 22-Dec-2010 61FCE55 3002906944 Apotex Inc. Canada
 
T94-0054141-1/2/1 02-Dec-2010 61FCS14 3001335107 Aurobindo Pharma Ltd India
 
T94-0054205-4/2/1 21-Dec-2010 61FCS14 3001335107 Aurobindo Pharma Ltd India
 
322-0309274-1/2/1 30-Dec-2010 61HAL99 3003696942 NWL Netherlands Production B.V. Netherlands
 
D04-0004954-6/1/1 03-Dec-2010 61HBJ99 3003140682 Emami Limited India
 
D04-0004954-6/4/1 03-Dec-2010 61HBJ99 3008580550 Kosmos Health Care (p) Ltd. India
 
D04-0004954-6/5/1 03-Dec-2010 61HBJ99 3003140682 Emami Limited India
 
112-5065591-1/1/1 03-Dec-2010 61HBL05 3000384282 Laboratorios Cheminova Internacional S.A. Spain
 
144-3588891-5/1/2 06-Dec-2010 61HBL99 3001687976 Toys R Us (Canada) Ltd Canada
 
144-3588891-5/1/1 06-Dec-2010 61HBL99 3001687976 Toys R Us (Canada) Ltd Canada
 
112-8814774-0/2/3 13-Dec-2010 61HCA14 3003615524 Glaxo Smith Kline India
 
AEK-8360116-7/1/2 03-Dec-2010 61JAA14 3008582802 Aprna Devi India
 
112-9305109-4/1/6 01-Dec-2010 61JCA14 3004896023 Merck United Laboratories Philippines
 
AEK-8360116-7/1/1 03-Dec-2010 61JDA16 3008582802 Aprna Devi India
 
AEK-9625602-5/2/2 06-Dec-2010 61JIK08 3003215132 Cipla Limited India
 
112-9305109-4/1/3 01-Dec-2010 61LCE38 3004109610 Metro Drug Co Philippines
 
112-9530754-3/1/1 03-Dec-2010 61MCA40 3006417191 Janssen-Cilag Ltd United Kingdom
 
UPS-0216975-9/1/1 07-Dec-2010 61NCY55 3008594562 Emilio Thodes Avalos Chile
 
UPS-0216975-9/1/2 07-Dec-2010 61NCY55 3008594562 Emilio Thodes Avalos Chile
 
112-9966926-1/6/1 08-Dec-2010 61PCA55 3002806851 Dr. Reddy's Laboratories Ltd, CTO Unit 1 India
 
112-9966926-1/3/1 08-Dec-2010 61PCA62 3002806851 Dr. Reddy's Laboratories Ltd, CTO Unit 1 India
 
112-9966926-1/4/1 08-Dec-2010 61PCA99 3002806851 Dr. Reddy's Laboratories Ltd, CTO Unit 1 India
 
M21-0742596-1/1/1 21-Dec-2010 61PCS55 3006623417 Granules India Limited India
 
112-9046671-7/2/1 08-Dec-2010 61TCS17 3008365293 Dong Gang Hong Da Pharm China
 
AEK-8566774-5/1/1 13-Dec-2010 61TCY31 3002093078 Vasudha Pharma Chem Limited India
 
AV3-0023165-9/2/9 28-Dec-2010 61VBL01 2244859 Novartis Consumer Health Inc. United States
 
AV3-0023165-9/2/12 28-Dec-2010 61VBL01 2244859 Novartis Consumer Health Inc. United States
 
M21-0742592-0/2/1 21-Dec-2010 61WAB04 3005144955 Chemo S.A. Lugano Branch Switzerland
 
820-4507906-6/1/1 02-Dec-2010 61WBM04 3008244351 Borshyagovskiy Chemical Pharmace Ukraine
 
M21-0742636-5/1/1 21-Dec-2010 61WCA47 3005144955 Chemo S.A. Lugano Branch Switzerland
 
417-0271158-5/1/1 20-Dec-2010 61WCS04 3002806963 Farchemia S.r.l. Italy
 
112-9548546-4/1/1 15-Dec-2010 61WQL99 3004105730 Merial Canada Inc Canada
 
820-4507906-6/19/1 02-Dec-2010 61XBA21 3008480555 Bristol-Myers Squibb France
 
-
-