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FDA Drug Application 022003 by SCHERING

Application Number022003
Application Type New Drug Application
Sponsor ApplicantSCHERING
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
AP09/15/2006N14839000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022003lbl.pdf 9/18/2006
AP09/15/2006N14898000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022003ltr.pdf 9/20/2006
AP09/15/2006N15338000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022003s000_NoxafilTOC.cfm 11/9/2006
AP05/20/2008SLR19871002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022003s002s006ltr.pdf 5/21/2008
AP05/20/2008SLR19872006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022003s002s006ltr.pdf 5/21/2008
AP02/19/2009SLR21892007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022003s007lbl.pdf 2/20/2009
AP02/19/2009SLR21900007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022003s007ltr.pdf 2/23/2009
AP09/8/2010SLR26447008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf 9/10/2010
AP09/8/2010SLR26478008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022003s008,022027s001ltr.pdf 9/13/2010
AP06/21/2012SLR32982011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf 6/22/2012
AP06/21/2012SLR32987011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf 6/25/2012
AP06/21/2012SLR32983012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf 6/22/2012
AP06/21/2012SLR32988012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf 6/25/2012
AP01/7/2014SCM       
AP06/16/2014SCM       
AP06/15/2015SCM       
AP07/14/2015SLR43389016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s016ltr.pdf 7/16/2015
AP07/14/2015SLR43441016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003Orig1s016lbl.pdf 7/22/2015
AP08/13/2015SCM       
AP011/16/2015SLR44500018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 11/18/2015
AP011/16/2015SLR44541018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf 11/19/2015
AP04/11/2016SCM       
AP011/16/2015SLR44501020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf 11/18/2015
AP011/16/2015SLR44542020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf 11/19/2015
AP09/9/2016SLR47032021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf 9/12/2016
AP09/9/2016SLR47040021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf 9/15/2016




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