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FDA Drug Application 021985 by NOVARTIS

Application Number021985
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/5/2007N15983000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021985lbl.pdf 3/7/2007
AP03/5/2007N16031000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021985s000ltr.pdf 3/15/2007
AP03/5/2007N16326000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000TOC.cfm 4/30/2007
AP03/5/2007N34446000   http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm 11/23/2012
AP08/7/2007SLR17617002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021985s002ltr.pdf 8/14/2007
AP02/15/2008SLR19239004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021985s004ltr.pdf 2/20/2008
AP05/19/2008SLR19861006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021985s006ltr.pdf 5/21/2008
AP011/10/2009SLR23907008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021985s008lbl.pdf 11/16/2009
AP011/10/2009SLR24610008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021985s008ltr.pdf 1/25/2010
AP08/4/2010SLR26197012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021985s012ltr.pdf 8/10/2010
AP08/4/2010SLR26232012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021985s012lbl.pdf 8/4/2010
AP02/10/2011SLR27818014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s014lbl.pdf 2/11/2011
AP02/10/2011SLR27832014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021985s014ltr.pdf 2/14/2011
AP010/12/2011SLR30332019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021985s019ltr.pdf 10/17/2011
AP010/12/2011SLR30368019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s019lbl.pdf 10/20/2011
AP01/26/2012SLR31590021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s021ltr.pdf 1/31/2012
AP01/26/2012SLR31614021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s021lbl.pdf 1/31/2012
AP02/2/2012SLR31676022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985Orig1s022LBL.pdf 2/6/2012
AP02/2/2012SLR31703022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s022ltrC.pdf 2/7/2012
AP04/16/2012SLR32453023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s023lbl.pdf 4/16/2012
AP04/16/2012SLR32465023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s023ltr.pdf 4/18/2012
AP09/28/2012SLR33882024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s024lbl.pdf 10/1/2012
AP09/28/2012SLR33917024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985Orig1s024ltr.pdf 10/2/2012
AP011/4/2013SLR37681025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021985s025lbl.pdf 11/4/2013
AP011/4/2013SLR37721025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021985Orig1s025ltr.pdf 11/7/2013
AP03/18/2014SLR38827026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021985s026lbl.pdf 3/19/2014
AP03/27/2015SLR42338027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021985Orig1s027ltr.pdf 4/1/2015
AP03/27/2015SLR42386027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s027lbl.pdf 4/2/2015
AP012/22/2015SLR44869028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021985Orig1s028ltr.pdf 12/23/2015
AP012/22/2015SLR44885028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s028lbl.pdf 12/28/2015




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