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FDA Drug Application 021107 by SEBELA IRELAND LTD

Application Number021107
Application Type New Drug Application
Sponsor ApplicantSEBELA IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/9/2000N1228000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21107ltr.pdf 2/9/2000
AP02/9/2000N1229000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21107a_Lotronex.cfm 8/29/2000
AP02/9/2000N1230000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21107lbl.pdf 2/9/2000
AP02/9/2000N7256000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110450.htm 12/17/2003
AP02/9/2000N26484000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088624.pdf 9/15/2010
AP02/9/2000N26590000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=29 10/1/2010
AP03/7/2000SCM18507001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021107_S001_LOTRONEX_TABLET.pdf 11/19/2007
AP08/11/2000SLR18506002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021107_S002_LOTRONEX_TABLET.pdf 11/19/2007
AP06/7/2002SE82985005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21107s5ltr.pdf 6/7/2002
AP06/7/2002SE82986005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21107s5lbl.pdf 6/7/2002
AP06/7/2002SE818505005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S005_LOTRONEX_TABLETS.pdf 11/19/2007
AP06/3/2002SCP18504006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S006_LOTRONEX_TABLETS.pdf 11/19/2007
AP03/20/2003SLR4501007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21107slr007ltr.pdf 3/26/2003
AP012/23/2003SCF7421008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21107scf008ltr.pdf 12/24/2003
AP012/23/2003SCF7438008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21107scf008_lotronex_lbl.pdf 12/29/2003
AP02/4/2005SLR11085010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021107s010lbl.pdf 2/4/2005
AP02/4/2005SLR11088010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21107s010ltr.pdf 2/8/2005
AP02/18/2005SLR11141011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21107s011ltr.pdf 2/23/2005
AP02/18/2005SLR11170011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21107s011lbl.pdf 2/23/2005
AP03/10/2006SLR13757012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021107s012lbl.pdf 3/14/2006
AP03/10/2006SLR13803012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021107s012ltr.pdf 3/23/2006
AP04/1/2008SE219627013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021107s013ltr.pdf 4/9/2008
AP04/1/2008SE219769013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021107s013lbl.pdf 5/6/2008
AP09/2/2010SLR26378014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021107s014ltr.pdf 9/7/2010
AP09/2/2010SLR26585014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s014lbl.pdf 10/1/2010
AP09/2/2010SLR26379016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021107s016ltr.pdf 9/7/2010
AP09/2/2010SLR26411016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf 9/7/2010
AP04/19/2013SCM       
AP05/8/2014SLR39286024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021107Orig1s024ltr.pdf 5/12/2014
AP07/24/2015S43495025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021107Orig1s025ltr.pdf 7/27/2015
AP01/7/2016SE844949026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021107Orig1s026ltr.pdf 1/11/2016
AP01/7/2016SLR44950027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021107Orig1s027ltr.pdf 1/11/2016
AP01/7/2016SLR45037027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021107s027lbl.pdf 1/26/2016
AP09/20/2016SCM       




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