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FDA Drug Application 021514 by NOVEN PHARMS INC

Application Number021514
Application Type New Drug Application
Sponsor ApplicantNOVEN PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative; New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/6/2006N13909000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021514s000ltr.pdf 4/13/2006
AP04/6/2006N16581000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 5/18/2007
AP04/6/2006N21230000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021514_daytrana_toc.cfm 11/14/2008
AP04/6/2006N23946000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088581.pdf 11/18/2009
AP07/27/2006SLR14585001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021514s001lbl.pdf 8/4/2006
AP07/27/2006SLR14614001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021514s001ltr.pdf 8/4/2006
AP02/5/2008SLR19123003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf 2/14/2008
AP05/1/2007SLR16430005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021514s005ltr.pdf 5/7/2007
AP05/1/2007SLR16451005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021514s005lbl.pdf 5/7/2007
AP02/5/2008SLR19124006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf 2/14/2008
AP02/5/2008SLR19125007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021514s003s006s007lbl.pdf 2/14/2008
AP012/14/2009SLR24294008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021514s008lbl.pdf 12/16/2009
AP012/14/2009SLR24341008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021514s008ltr.pdf 12/24/2009
AP06/29/2010SLR25897009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021514s009,s010ltr.pdf 7/2/2010
AP06/29/2010SE125898010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021514s009,s010ltr.pdf 7/2/2010
AP06/29/2010SE125917010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021514s009s010MedGuide.pdf 7/6/2010
AP06/29/2010SE125918010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021514s009s010lbl.pdf 7/6/2010
AP010/18/2010SLR26689011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021514s011lbl.pdf 10/18/2010
AP010/18/2010SLR26721011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021514s011ltr.pdf 10/20/2010
AP011/21/2012SCM       
AP06/6/2013SLR36240015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s015lbl.pdf 6/7/2013
AP06/6/2013SLR36243015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021514Orig1s015ltr.pdf 6/7/2013
AP05/9/2013SCM       
AP012/12/2013SLR38045017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021514Orig1s017ltr.pdf 12/16/2013
AP012/12/2013SLR38057017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021514s017lbl.pdf 12/17/2013
AP011/9/2015SCM       
AP04/14/2015SCM       
AP04/14/2015SCM       
AP04/17/2015SLR42575022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021514Orig1s022ltr.pdf 4/20/2015
AP04/17/2015SLR42599022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s022lbl.pdf 4/21/2015
AP08/14/2015SLR43659023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s023lbl.pdf 8/17/2015
AP08/14/2015SLR43665023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021514Orig1s023ltr.pdf 8/18/2015
AP08/19/2016SLR46829024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021514Orig1s024ltr.pdf 8/22/2016
AP08/19/2016SLR46860024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021514s024lbl.pdf 8/23/2016




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