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FDA Drug Application 022185 by LEO PHARMA AS

Application Number022185
Application Type New Drug Application
Sponsor ApplicantLEO PHARMA AS
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
AP05/9/2008N22240000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022185_taclonex_scalp_toc.cfm 4/14/2009
AP05/9/2008N19836000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022185s000ltr.pdf 5/15/2008
AP05/9/2008N20251000   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022185s000_SUMR.pdf 7/17/2008
AP03/20/2009SCP22094003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022185s003ltr.pdf 3/24/2009
AP010/17/2012SE134124010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s010lbl.pdf 10/18/2012
AP010/17/2012SE134136010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s010ltr.pdf 10/22/2012
AP011/30/2012SLR34525012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s012ltr.pdf 12/4/2012
AP011/30/2012SLR34541012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s012lbl.pdf 12/4/2012
AP06/28/2013SCM       
AP011/7/2013SCM37856015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf 11/19/2013
AP011/7/2013SCM37756015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016ltr.pdf 11/8/2013
AP011/7/2013SLR37759016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf 11/8/2013
AP011/7/2013SLR37755016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016ltr.pdf 11/8/2013
AP02/26/2014SCM       
AP08/29/2014SE840368018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s018ltr.pdf 9/3/2014
AP08/29/2014SE840402018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s018lbl.pdf 9/3/2014
AP010/29/2015SCM44372019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022185s019lbl.pdf 11/4/2015
AP07/28/2014SLR40029020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s020ltr.pdf 7/29/2014
AP07/28/2014SLR40041020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s020lbl.pdf 7/29/2014
AP02/5/2016SCM       
AP03/18/2016SCM       
AP06/21/2016SCM46410024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022185s024lbl.pdf 6/23/2016




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