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FDA Drug Application 021802 by NOVARTIS

Application Number021802
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/26/2005N11755000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021802ltr.pdf 6/7/2005
AP05/26/2005N11763000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021802lbl.pdf 6/7/2005
AP05/26/2005N16555000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 5/10/2007
AP05/26/2005N16872000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021802s000TOC.cfm 7/2/2007
AP05/26/2005N23711000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088601.pdf 10/30/2009
AP04/11/2006SE813899001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf 4/12/2006
AP04/11/2006SE813918001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s001, s005ltr.pdf 4/13/2006
AP08/1/2006SLR14590003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf 8/4/2006
AP08/1/2006SLR14598003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s007, s003LTR.pdf 8/4/2006
AP04/11/2006SLR13919005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s001, s005ltr.pdf 4/13/2006
AP04/11/2006SLR13900005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf 4/12/2006
AP08/1/2006SCS14591007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf 8/4/2006
AP08/1/2006SCS14599007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s007, s003LTR.pdf 8/4/2006
AP04/25/2007SLR16355009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf 5/1/2007
AP04/25/2007SLR16390009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s008,021802s009ltr.pdf 5/1/2007
AP010/17/2008SLR21046012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021802s012ltr.pdf 10/22/2008
AP010/23/2009SE223700014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf 10/30/2009
AP010/23/2009SE224250014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021802s014,s016ltr.pdf 12/11/2009
AP010/23/2009SLR24251016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021802s016ltr.pdf021802s014,s016ltr.pdf 12/11/2009
AP010/23/2009SLR23701016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf 10/30/2009
AP05/4/2010SLR25480017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s017ltr.pdf 5/7/2010
AP05/4/2010SLR25482017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s017lbl.pdf 5/7/2010
AP011/15/2010SLR26990021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s021lbl.pdf 11/19/2010
AP011/15/2010SLR26992021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s021,021278s012ltr.pdf 11/22/2010
AP04/21/2011SCM30784022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021802s022lbl.pdf 11/29/2011
AP05/2/2012SLR32619024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021802s024,021278s015ltr.pdf 5/4/2012
AP05/2/2012SLR32625024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021802s024lbl.pdf 5/7/2012
AP06/11/2013SLR36281025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021802Orig1s025,021278Orig1s016ltr.pdf 6/12/2013
AP06/11/2013SLR36319025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s025lbl.pdf 6/18/2013
AP012/12/2013SLR38040026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021278Orig1s017,021802Orig1s026ltr.pdf 12/13/2013
AP012/12/2013SLR38056026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s026lbl.pdf 12/17/2013
AP06/12/2015SCM       
AP04/17/2015SLR42580028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021278Orig1s018,021802Orig1s028ltr.pdf 4/20/2015
AP04/17/2015SLR42607028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf 4/21/2015
AP012/4/2015SCM       




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