• 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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-2232377-9/2/1 22-Sep-2008 62BCY08 3000245736 Novartis Biociencias S.A. Brazil
 
112-4141252-0/3/2 03-Sep-2008 62CCP65 3005314505 Sandoz International Gmbh Germany
 
DO7-8203923-7/1/1 29-Sep-2008 62CDB99 3004905736 Roche Farma Sa Spain
 
AA8-0016692-5/17/1 19-Sep-2008 62FAL20 3005384829 Laboratorios Rangel C. Por A. Dominican Republic
 
AA8-0016692-5/25/1 19-Sep-2008 62FAL20 3005384829 Laboratorios Rangel C. Por A. Dominican Republic
 
EL0-0224017-3/20/1 05-Sep-2008 62FBJ99 3006744199 Makson Industries Pvt. Ltd. India
 
AA8-0016692-5/19/1 19-Sep-2008 62FBL14 3005384829 Laboratorios Rangel C. Por A. Dominican Republic
 
AEK-9555035-2/1/1 11-Sep-2008 62FCK99 3007081983 Gerald Seftel South Africa
 
112-2162765-9/1/1 26-Sep-2008 62GAC99 3006757962 Positive Health Clinic Pvt Ltd India
 
FL2-0030184-2/1/1 22-Sep-2008 62GAS18 3003743917 Kairav Chemicals Ltd India
 
112-4352900-8/1/1 19-Sep-2008 62GBY82 3005794455 Aestus Corp Canada
 
UPS-2150886-4/1/2 10-Sep-2008 62GCA18 3005402689 Merck S.A. Mexico
 
AEK-9134503-9/2/1 18-Sep-2008 62GCA99 3007115179 Dr Lall India
 
112-2513826-5/1/1 30-Sep-2008 62GCB91 3008865002 Pharco Pharmaceutticals Egypt
 
XXX-0155117-6/1/1/L 12-Sep-2008 62GDJ17 3001078914 Laboratoires Roussel France
 
M21-0738332-7/5/1 22-Sep-2008 62GDL18 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
112-3901838-8/1/1 03-Sep-2008 62IIS79 3002807910 Pharmachemie B.V. Netherlands
 
112-2382653-1/1/2 24-Sep-2008 62KCB10 3005528152 Farmacoop Colombia
 
AEK-9131263-3/4/1 19-Sep-2008 62KCH10 3007083495 Gautam Magrath India
 
470-0060937-1/1/1 04-Sep-2008 62KCY10 3003121577 Laboratorios Dr. Esteve SA Spain
 
112-4141252-0/3/1 03-Sep-2008 62LBN50 3005224455 Denk Pharma Germany
 
112-3944245-5/1/1 03-Sep-2008 62LCB50 3004915831 Lab Genfar Sa Colombia
 
112-4076699-1/1/1 10-Sep-2008 62LDB44 3004433220 Glaxosmithkline Gmbh & Co Germany
 
144-8403225-7/1/1 04-Sep-2008 62MAY08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
144-8403225-7/1/2 04-Sep-2008 62MAY08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
144-8403225-7/1/3 04-Sep-2008 62MAY08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
144-8403225-7/1/4 04-Sep-2008 62MAY08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
XXX-0155459-2/1/1/D 17-Sep-2008 62MDJ01 3006742009 PZ Nigeria Limited Nigeria
 
M21-0738332-7/2/1 22-Sep-2008 62OAB22 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
M21-0738332-7/1/1 22-Sep-2008 62OAB22 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
112-4141252-0/5/1 03-Sep-2008 62OAP09 3007692005 Boehringer Ingelheim Pharma GMBH & Co Germany
 
112-4141252-0/2/1 03-Sep-2008 62OBP29 3003388833 Ranbaxy Laboratories Limited India
 
112-4141252-0/1/2 03-Sep-2008 62OBP34 1000448661 Bristol Myers Tvl United States
 
AEK-9533847-7/1/8 02-Sep-2008 62OCA09 3007041622 Rose Janzen Canada
 
AEK-9131263-3/3/1 19-Sep-2008 62OCB14 3007083495 Gautam Magrath India
 
112-0710608-2/1/2 17-Sep-2008 62OCH12 3000281296 Novartis Pharma Canada Canada
 
112-4141252-0/2/2 03-Sep-2008 62OCP29 3003699941 Cipla Ltd India
 
112-0710608-2/1/1 17-Sep-2008 62OCP44 3000281296 Novartis Pharma Canada Canada
 
XXX-0137804-2/1/1 09-Sep-2008 62ODY41 3003962829 Unichem Laboratories Ltd India
 
112-4018571-3/1/1 19-Sep-2008 62ORA15 3004809965 Novartis Consumer Health S.A. Spain
 
AEK-9533847-7/1/4 02-Sep-2008 62TAE02 3007041622 Rose Janzen Canada
 
XXX-0149090-4/3/1 09-Sep-2008 62UAA08 1000323905 Bristol Myers Squibb France
 
WUG-0142837-3/23/1 10-Sep-2008 62UBY99 3006297567 J. D. Corporation India
 
112-2459542-4/2/1 24-Sep-2008 62VCB37 3000205956 Agouron Pharmaceuticals Inc United States
 
112-2459542-4/1/2 24-Sep-2008 62VCB52 3005129054 Glaxosmithkline Chile Farmaceutica Ltda Chile
 
112-4349917-8/1/1 19-Sep-2008 62VCP99 3004357582 Sciclone Pharm Int'L Ltd Hong Kong SAR
 
112-4350288-0/1/2 19-Sep-2008 62ZCY10 3004688903 Sanofi Synthelabo United Kingdom
 
-
-