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FDA Drug Application 020273 by LEO PHARMA AS

Application Number020273
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
AP012/29/1993N       
AP08/15/1996SE2       
AP07/13/1995SCS       
AP03/20/1997SE2       
AP07/7/1999SE8969004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20273s4ltr.pdf 7/7/1999
AP07/7/1999SE8970004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20273S004_Dovonex.pdf 7/7/1999
AP03/11/1999SCS       
AP01/11/2000SLR       
AP03/23/2001SCP       
AP04/28/2005SLR21622008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020273_s008_DOVONEX.pdf 1/12/2009
AP04/28/2005SLR11549008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020273s008ltr.pdf 5/2/2005
AP04/28/2005SLR11556008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020273s008lbl.pdf 5/2/2005
AP09/26/2007SLR18142009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf 10/4/2007
AP09/26/2007SLR18172009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf 10/4/2007
AP07/3/2014SCM       
AP03/11/2015SLR42148013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020554Orig1s12,020273Orig1s13ltr.pdf 3/13/2015
AP03/11/2015SLR42169013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf 3/17/2015




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