Back to FDA Applications sponsored by NOVARTIS

FDA Drug Application 022011 by NOVARTIS

Application Number022011
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
AP010/25/2006N24199000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135934.pdf 12/4/2009
AP010/25/2006N15246000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022011lbl.pdf 10/26/2006
AP010/25/2006N15279000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022011s000ltr.pdf 10/27/2006
AP010/25/2006N15489000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/22011s000TOC.cfm 12/22/2006
AP01/23/2009SE821679001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022011s001ltr.pdf 1/26/2009
AP01/23/2009SE821787001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022011s001lbl.pdf 2/4/2009
AP05/8/2009SLR22564002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022011s002lbl.pdf 5/13/2009
AP05/8/2009SLR22568002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022011s002ltr.pdf 5/13/2009
AP03/4/2010SLR24999003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022011s003,022154s001ltr.pdf 3/8/2010
AP03/4/2010SLR25015003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s003,022154s001lbl.pdf 3/9/2010
AP09/10/2010SLR26488006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022154s003,022011s006ltr.pdf 9/16/2010
AP09/10/2010SLR26599006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s006,022154s003lbl.pdf 10/4/2010
AP03/29/2011SLR28414009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s009,022154s006ltr.pdf 4/1/2011
AP03/29/2011SLR28426009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011s009,022154s006lbl.pdf 4/1/2011
AP01/28/2013SE834997010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s010lbl.pdf 1/28/2013
AP05/5/2011SLR28755011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s011,022154s008ltr.pdf 5/10/2011
AP012/23/2011SLR31245012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011S012,022154S009lbl.pdf 12/23/2011
AP012/23/2011SLR31323012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s012,022154s009ltr.pdf 1/3/2012
AP01/28/2013SE834996013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013lbl.pdf 1/28/2013
AP01/28/2013SE835009013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022011Orig1s013,022154Orig1s010ltr.pdf 1/30/2013
AP012/6/2013SCM       
AP012/11/2015SCM       




Back to FDA Applications sponsored by NOVARTIS