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FDA Drug Application 019618 by MEDA PHARMS

Application Number019618
Application Type New Drug Application
Sponsor ApplicantMEDA 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
AP012/24/1987N       
AP011/7/1988SCM       
AP05/24/1989SLR       
AP08/20/1991SCS       
AP03/31/1992SCP       
AP02/19/1992SLR       
AP011/22/1993SLR       
AP07/22/1996SCM       
AP010/1/2001SLR       
AP07/26/2002SCS       
AP012/29/2005SLR13354016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019618s016.pdf 1/6/2006
AP06/20/2008SCF20060018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019618s018ltr.pdf 6/24/2008
AP06/20/2008SCF42899018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf 5/26/2015
AP03/24/2016SCM       




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