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FDA Drug Application 019715 by MEDA PHARMS

Application Number019715
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
AP07/31/1990N       
AP08/9/1993SCS       
AP01/5/1993SLR       
AP03/15/1993SLR       
AP01/26/1995SCF       
AP012/8/1993SLR       
AP05/24/1994SCM       
AP05/26/1994SCM       
AP09/22/1994SCS       
AP06/4/1996SCM       
AP03/23/1995SCM       
AP06/12/1996SCM       
AP01/31/1996SCP       
AP02/8/1995SLR       
AP01/29/1996SCS       
AP09/11/1996SCM       
AP06/6/1996SCP       
AP06/30/1999SLR       
AP01/18/2002SLR1710018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715s18ltr.pdf 1/18/2002
AP09/8/2000SLR       
AP02/14/2001SCP       
AP08/9/2002SCP1709021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715scs021ltr.pdf 8/9/2002
AP011/12/2002SCM       
AP07/10/2007SLR17282025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019715s025ltr.pdf 7/16/2007
AP08/5/2009SLR23170027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019715s027lbl.pdf 8/13/2009
AP08/5/2009SLR23840027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019715s027ltr.pdf 11/12/2009




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