Back to FDA Applications sponsored by NOVARTIS PHARMS CORP

FDA Drug Application 022059 by NOVARTIS PHARMS CORP

Application Number022059
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/13/2007N16010000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059lbl.pdf 3/13/2007
AP03/13/2007N16018000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s000ltr.pdf 3/15/2007
AP03/13/2007N16457000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022059s000TOC.cfm 5/9/2007
AP04/27/2007SLR16332001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s001lbl.pdf 5/1/2007
AP04/27/2007SLR16366001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s001ltr.pdf 5/1/2007
AP08/20/2007SLR17656002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s002lbl.pdf 8/21/2007
AP08/20/2007SLR17679002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s002ltr.pdf 8/22/2007
AP01/29/2010SLR24687003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf 2/1/2010
AP01/29/2010SLR25011003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s003s006ltr.pdf 3/9/2010
AP07/7/2008SLR20169004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022059s004lbl.pdf 7/9/2008
AP07/7/2008SLR20186004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022059s004ltr.pdf 7/10/2008
AP01/29/2010SLR24688006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf 2/1/2010
AP01/29/2010SLR25010006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s003s006ltr.pdf 3/9/2010
AP01/29/2010SE124686007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s007lbl.pdf 2/1/2010
AP01/29/2010SE124730007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s007ltr.pdf 2/5/2010
AP08/12/2011SLR29774011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf 8/12/2011
AP08/12/2011SLR29786011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022059s011,s012ltr.pdf 8/15/2011
AP08/12/2011SLR29775012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf 8/12/2011
AP08/12/2011SLR29787012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022059s011,s012ltr.pdf 8/15/2011
AP02/14/2012SLR31830013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022059s013lbl.pdf 2/17/2012
AP02/14/2012SLR31835013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022059Orig1s013ltr.pdf 2/21/2012
AP06/21/2013SLR36368015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s015,s018ltr.pdf 6/24/2013
AP06/21/2013SLR36377015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf 6/25/2013
AP010/18/2013SE837489016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s016,s017ltr.pdf 10/22/2013
AP010/18/2013SE837523016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf 10/22/2013
AP010/18/2013SE837490017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s016,s017ltr.pdf 10/22/2013
AP010/18/2013SE837524017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf 10/22/2013
AP06/21/2013SLR36367018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s015,s018ltr.pdf 6/24/2013
AP06/21/2013SLR36378018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf 6/25/2013
AP03/31/2015SLR42360020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022059s020lbl.pdf 4/1/2015
AP03/31/2015SLR42381020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022059Orig1s020ltr.pdf 4/2/2015
AP012/22/2014SLR41434021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022059Orig1s021ltr.pdf 12/30/2014
AP012/22/2014SLR41477021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022059Orig1s021lbl.pdf 1/5/2015




Back to FDA Applications sponsored by NOVARTIS PHARMS CORP