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FDA Drug Application 022071 by NOVARTIS

Application Number022071
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
AP09/28/2007N18128000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022071s000ltr.pdf 10/4/2007
AP09/28/2007N18164000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022071lbl.pdf 10/4/2007
AP09/28/2007N21991000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022071_lamisil_toc.cfm 3/12/2009
AP012/2/2010SLR27162003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022071s003lbl.pdf 12/4/2010
AP012/2/2010SLR27246003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022071s003ltr.pdf 12/7/2010
AP03/30/2011SLR28412004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022071s004ltr.pdf 3/31/2011
AP03/30/2011SLR28430004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022071s004lbl.pdf 4/1/2011
AP011/4/2011SLR30536006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022071s006ltr.pdf 11/8/2011
AP04/23/2012SLR32522007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022071s007lbl.pdf 4/23/2012
AP04/23/2012SLR32532007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022071s007ltr.pdf 4/25/2012
AP06/17/2013SLR36313009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022071s009lbl.pdf 6/17/2013
AP06/17/2013SLR36338009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022071Orig1s009ltr.pdf 6/18/2013
AP010/23/2013SLR37558010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022071Orig1s010ltr.pdf 10/25/2013
AP010/23/2013SLR37586010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022071s010lbl.pdf 10/25/2013
AP08/23/2016SLR46881011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022071Orig1s011ltr.pdf 8/25/2016
AP08/23/2016SLR47321011   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524717.pdf 10/12/2016




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