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FDA Drug Application 020554 by LEO PHARMA AS

Application Number020554
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
AP07/22/1996N       
AP012/18/1998SCS       
AP03/11/1999SCS       
AP01/11/2000SLR       
AP03/23/2001SCP       
AP04/28/2005SLR11551006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020554s006ltr.pdf 5/2/2005
AP04/28/2005SLR11558006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020554s006lbl.pdf 5/2/2005
AP09/26/2007SLR18143007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf 10/4/2007
AP09/26/2007SLR18173007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf 10/4/2007
AP06/12/2014SCM       
AP01/14/2014SCM       
AP011/21/2013SCM       
AP03/11/2015SLR42147012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020554Orig1s12,020273Orig1s13ltr.pdf 3/13/2015
AP03/11/2015SLR42170012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf 3/17/2015




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