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FDA Drug Application 050777 by LEO PHARMA AS

Application Number050777
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
AP012/8/2000N11405000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107845.htm 4/15/2005
AP012/8/2000N4966000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50777lbl.pdf 4/7/2003
AP012/8/2000N5061000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50777ltr.pdf 4/9/2003
AP012/8/2000N5407000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50777_protopic.cfm 4/22/2003
AP06/26/2001SCP       
AP06/13/2002SCS       
AP011/22/2002SCS       
AP04/18/2003SCP5679004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50777scp004_protopic_lbl.pdf 5/29/2003
AP04/18/2003SCP5709004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50777scp004ltr.pdf 5/29/2003
AP012/23/2003SCS7423006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50777scs006ltr.pdf 12/24/2003
AP012/23/2003SCS7441006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50777scs006_protopic_lbl.pdf 12/29/2003
AP07/14/2005SCP12010010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050777s010ltr.pdf 7/15/2005
AP01/19/2006SLR13421012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050777s012lbl.pdf 1/19/2006
AP01/19/2006SLR13423012   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088996.pdf 1/19/2006
AP01/19/2006SLR13565012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/05077s012ltr.pdf 1/30/2006
AP012/31/2008SCM21530014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050777s014ltr.pdf 1/6/2009
AP011/4/2011SLR30535018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050777s018ltr.pdf 11/8/2011
AP011/4/2011SLR30638018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050777s018lbl.pdf 11/17/2011




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