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FDA Drug Application 020484 by LEO PHARMA AS

Application Number020484
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
AP07/14/2000N1899000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-484_Innohep.cfm 7/14/2000
AP07/14/2000N48000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20484ltr.pdf 7/14/2000
AP07/14/2000N49000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20484lbl.pdf 7/14/2000
AP011/21/2000SCS       
AP02/5/2002SLR1898002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20484s2ltr.pdf 2/5/2002
AP03/4/2003SLR9121003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20484slr003ltr.pdf 6/7/2004
AP011/7/2006SLR15333006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020484s006LTR.pdf 11/9/2006
AP012/29/2008SLR21428011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020484s011ltr.pdf 12/30/2008
AP012/29/2008SLR21463011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020484s011lbl.pdf 1/2/2009
AP012/23/2009SLR24376013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020484s013lbl.pdf 12/30/2009
AP012/23/2009SLR24381013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020484s013ltr.pdf 12/31/2009
AP010/7/2010SLR26620014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020484s014lbl.pdf 10/12/2010
AP010/7/2010SLR26653014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020484s014ltr.pdf 10/13/2010




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