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FDA Drug Application 202833 by LEO PHARMA AS

Application Number202833
Application Type New Drug Application
Sponsor ApplicantLEO PHARMA AS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/23/2012N31516000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202833lbl.pdf 1/25/2012
AP01/23/2012N31570000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202833s000ltr.pdf 1/30/2012
AP01/23/2012N31998000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202833Orig1s000TOC.cfm 3/2/2012
AP03/12/2014SLR38795002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202833Orig1s002ltr.pdf 3/14/2014
AP03/12/2014SLR38915002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202833Orig1s002lbl.pdf 3/26/2014
AP02/3/2015SCM       
AP011/19/2015S44553004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202833Orig1s004ltr.pdf 11/20/2015
AP011/19/2015S44593004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s004lbl.pdf 11/25/2015
AP010/6/2015SLR44144005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202833Orig1s005ltr.pdf 10/7/2015
AP010/6/2015SLR44179005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s005lbl.pdf 10/8/2015
AP04/15/2016SCM       
AP09/13/2016SLR47048007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202833Orig1s007ltr.pdf 9/15/2016
AP09/13/2016SLR47061007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202833s007lbl.pdf 9/15/2016




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