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FDA Drug Application 018917 by PROMIUS PHARMA

Application Number018917
Application Type New Drug Application
Sponsor ApplicantPROMIUS PHARMA
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
AP012/28/1984N       
AP02/6/1985SLR       
AP08/28/1985SCP       
AP06/9/1986SCS       
AP06/25/1986SLR       
AP06/11/1987SLR       
AP05/4/1987SLR       
AP012/5/1988SCP       
AP011/20/1987SCM       
AP08/18/1987SCP       
AP012/18/1987SCP       
AP03/24/1989SCM       
AP012/5/1988SLR       
AP010/3/1988SCF       
AP08/10/1989SLR       
AP011/7/1997SLR       
AP08/22/1999SLR       
AP07/13/2001SCM       
AP09/6/2007SLR17824024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018917s024lbl.pdf 9/11/2007
AP09/6/2007SLR17869024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018917s024_ltr.pdf 9/11/2007
AP03/3/2011SLR28104025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018917s025ltr.pdf 3/7/2011
AP03/3/2011SLR38804025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018917s025lbl.pdf 3/17/2014




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