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FDA Drug Application 018299 by MONARCH PHARMS

Application Number018299
Application Type New Drug Application
Sponsor ApplicantMONARCH PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/10/1980N       
AP06/27/1980SCS       
AP012/30/1980SCM       
AP08/20/1981SCE       
AP03/14/1983SCS       
AP012/5/1988SLR       
AP012/30/1991SLR       
AP05/8/1995SCS       
AP010/17/1997SLR       
AP03/6/1997SCM       
AP012/10/1996SCS       
AP012/31/1996SCS       
AP02/10/1997SCS       
AP02/20/2002SLR2800014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18299s014ltr.pdf 2/20/2002




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