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FDA Drug Application 017765 by PROMIUS PHARMA LLC

Application Number017765
Application Type New Drug Application
Sponsor ApplicantPROMIUS PHARMA LLC
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
AP08/22/1977N       
AP010/19/1977SLR       
AP01/9/1980SCE       
AP01/22/1980SCS       
AP05/8/1980SCS       
AP06/24/1980SDS       
AP06/24/1980SCM       
AP08/14/1980SCM       
AP010/31/1980SCM       
AP03/2/1981SCM       
AP08/3/1983SCS       
AP06/1/1983SCM       
AP05/31/1984SCS       
AP02/7/1986SCP       
AP05/17/1988SCM       
AP010/27/1989SCS       
AP03/12/1999SCM       
AP06/15/1999SCM       
AP09/27/2000SCF       
AP01/11/2001SCS       
AP03/14/2002SCP       
AP012/10/2003SCP7249024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17765scp024ltr.pdf 12/16/2003
AP012/10/2003SCP7250024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17765scp024_cloderm_lbl.pdf 12/16/2003




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