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FDA Drug Application 022291 by NOVARTIS PHARMS CORP

Application Number022291
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/20/2008N21255000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022291lbl.pdf 11/21/2008
AP011/20/2008N21287000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022291s000ltr.pdf 11/26/2008
AP011/20/2008N21640000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022291s000_TOC.cfm 1/14/2009
AP011/20/2008N21641000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022291s000_SumR.pdf 1/14/2009
AP011/20/2008N24055000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088990.pdf 11/20/2009
AP02/25/2011SE728007001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022291s001ltr.pdf 3/2/2011
AP02/25/2011SE728056001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s001lbl.pdf 3/4/2011
AP03/5/2010SLR25008003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022291s003ltr.pdf 3/9/2010
AP012/6/2011SLR30883006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf 12/6/2011
AP012/6/2011SLR30890006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022291s006ltr.pdf 12/7/2011
AP011/16/2012SE134428008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022291s008lbl.pdf 11/19/2012
AP011/16/2012SE134435008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022291Orig1s008ltr.pdf 11/19/2012
AP02/10/2014SLR38501010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf 2/11/2014
AP02/10/2014SLR38504010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s010ltr.pdf 2/12/2014
AP04/10/2014SLR39149011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s011ltr.pdf 4/28/2014
AP04/10/2014SLR39152011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291Orig1s011lbl.pdf 4/28/2014
AP08/26/2014SE840325012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s012lbl.pdf 8/27/2014
AP08/26/2014SE840330012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s012ltr.pdf 8/28/2014
AP07/16/2014SLR39888013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s013ltr.pdf 7/17/2014
AP04/7/2015SLR42473014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022291Orig1s014ltr.pdf 4/8/2015
AP04/7/2015SLR42492014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s014lbl.pdf 4/10/2015
AP06/11/2015SE843051015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022291Orig1s015ltr.pdf 6/12/2015
AP06/11/2015SE843054015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s015lbl.pdf 6/12/2015
AP010/12/2016SLR47362016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022291Orig1s016,207027Orig1s001ltr.pdf 10/14/2016
AP010/12/2016SLR47372016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf 10/17/2016




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