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FDA Drug Application 021817 by NOVARTIS

Application Number021817
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/16/2007N16230000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021817s000ltr.pdf 4/20/2007
AP04/16/2007N16266000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021817lbl.pdf 4/20/2007
AP04/16/2007N19462000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021817TOC.cfm 3/14/2008
AP04/16/2007N36008000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241522.pdf 5/9/2013
AP06/3/2008SE119966001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021817s001ltr.pdf 6/6/2008
AP06/3/2008SE120035001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021817s001lbl.pdf 6/19/2008
AP06/3/2008SE120244001   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021817se1-001_SUMR.pdf 7/17/2008
AP012/19/2008SE121436002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021817s002ltr.pdf 12/31/2008
AP012/19/2008SE121501002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021817s002lbl.pdf 1/6/2009
AP03/13/2009SE122046003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021817s003ltr.pdf 3/19/2009
AP03/13/2009SE122299003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021817s003lbl.pdf 4/21/2009
AP05/29/2009SE122721004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021817s004ltr.pdf 6/10/2009
AP05/29/2009SE122738004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021817s004lbl.pdf 6/10/2009
AP03/8/2011SLR28208006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s006ltr.pdf 3/10/2011
AP03/8/2011SLR28228006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s006lbl.pdf 3/11/2011
AP03/8/2011SLR28229006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s006MedG.pdf 3/11/2011
AP01/25/2011SLR27613009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s009MedG.pdf 1/26/2011
AP01/25/2011SLR27614009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s009lbl.pdf 1/26/2011
AP01/25/2011SLR27619009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s009ltr.pdf 1/27/2011
AP08/31/2011SLR29936012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s012lbl.pdf 9/1/2011
AP08/31/2011SLR29937012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021817s012MedG.pdf 9/1/2011
AP08/31/2011SLR29938012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s012ltr.pdf 9/1/2011
AP08/31/2011SLR34974012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021817Orig1s012.pdf 1/24/2013
AP08/15/2011SLR29808013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021817s013ltr.pdf 8/17/2011
AP07/23/2013SCM       
AP04/19/2013SLR35801015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021817s015lbl.pdf 4/23/2013
AP04/19/2013SLR35819015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021817Orig1s015ltr.pdf 4/24/2013
AP09/17/2013SCM       
AP05/13/2014SCM       
AP06/17/2014SCM       
AP01/30/2015SLR41754020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021817Orig1s020ltr.pdf 2/2/2015
AP01/30/2015SLR41877020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021817s020lbl.pdf 2/19/2015
AP04/16/2015SLR42568021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021817s021lbl.pdf 4/19/2015
AP04/16/2015SLR42772021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021817Orig1s021ltr.pdf 5/11/2015
AP04/14/2016SLR45686022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021817s022lbl.pdf 4/15/2016
AP04/14/2016SLR45689022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021817Orig1s022ltr.pdf 4/15/2016
AP05/24/2016SCM       




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