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FDA Drug Application 022154 by NOVARTIS

Application Number022154
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
AP04/28/2009N22436000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022154s000ltr.pdf 5/6/2009
AP04/28/2009N22494000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022154lbl.pdf 5/11/2009
AP04/28/2009N23813000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022154_tyzeka_toc.cfm 11/10/2009
AP04/28/2009N23814000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022154s000_SumR.pdf 11/10/2009
AP04/28/2009N24200000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135934.pdf 12/4/2009
AP03/4/2010SLR25000001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022011s003,022154s001ltr.pdf 3/8/2010
AP03/4/2010SLR25014001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s003,022154s001lbl.pdf 3/9/2010
AP09/10/2010SLR26489003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022154s003,022011s006ltr.pdf 9/16/2010
AP09/10/2010SLR26600003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022011s006,022154s003lbl.pdf 10/4/2010
AP03/29/2011SLR28415006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s009,022154s006ltr.pdf 4/1/2011
AP03/29/2011SLR28425006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011s009,022154s006lbl.pdf 4/1/2011
AP05/5/2011SLR28756008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s011,022154s008ltr.pdf 5/10/2011
AP012/23/2011SLR31244009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022011S012,022154S009lbl.pdf 12/23/2011
AP012/23/2011SLR31324009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022011s012,022154s009ltr.pdf 1/3/2012
AP01/28/2013SE835010010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022011Orig1s013,022154Orig1s010ltr.pdf 1/30/2013
AP01/28/2013SE835144010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013,022154s010lbl.pdf 2/12/2013
AP012/6/2013SCM       
AP01/30/2014SCM       




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