Back to FDA Applications sponsored by LEO PHARMA AS

FDA Drug Application 021852 by LEO PHARMA AS

Application Number021852
Application Type New Drug Application
Sponsor ApplicantLEO PHARMA AS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/9/2006N13380000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021852lbl.pdf 1/13/2006
AP01/9/2006N13442000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021852s000ltr.pdf 1/20/2006
AP01/9/2006N19517000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021852TOC.cfm 3/24/2008
AP09/26/2007SLR18136002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021852s002ltr.pdf 10/4/2007
AP09/26/2007SLR18175002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021852s002lbl.pdf 10/4/2007
AP03/30/2010SLR25185006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021852s006ltr.pdf 4/2/2010
AP03/30/2010SLR25195006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021852s006lbl.pdf 4/4/2010
AP06/12/2014SCM       
AP011/30/2012SLR34519012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021852s012lbl.pdf 12/3/2012
AP011/30/2012SLR34522012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021852Orig1s012ltr.pdf 12/4/2012
AP04/25/2013SCM       
AP03/13/2014SCM       
AP012/23/2014SE841437015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s015ltr.pdf 12/30/2014
AP012/23/2014SE841548015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s015lbl.pdf 1/8/2015
AP07/28/2014SLR40034016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s016ltr.pdf 7/29/2014
AP07/28/2014SLR40042016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s016lbl.pdf 7/29/2014




Back to FDA Applications sponsored by LEO PHARMA AS