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FDA Drug Application 018983 by MEDA PHARMS

Application Number018983
Application Type New Drug Application
Sponsor ApplicantMEDA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/26/1984N       
AP08/19/1986SLR       
AP03/27/1986SCE       
AP08/19/1986SCM       
AP06/12/1987SCM       
AP01/31/1989SCS       
AP01/31/1989SLR       
AP011/14/1991SCF       
AP06/26/1990SCP       
AP03/5/1993SCP       
AP04/25/1994SCE       
AP04/25/1994SCE       
AP02/24/1994SCM       
AP06/6/1994SCS       
AP04/4/1994SCF       
AP010/13/1994SCM       
AP01/24/1996SCF       
AP09/6/1996SCM       
AP01/21/1997SCM       
AP012/9/1997SCM       
AP010/8/1998SCP       
AP04/17/1998SCP       
AP07/21/1999SCP       
AP011/30/1999SCM       
AP010/16/2000SLR       
AP010/16/2000SLR       
AP07/20/2000SCM       
AP010/12/2000SCM       
AP05/16/2002SCM       
AP09/16/2002SLR2546035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18983slr035ltr.pdf 9/16/2002
AP011/12/2002SCM       
AP010/23/2003SLR6953037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18983slr037ltr.pdf 11/25/2003
AP04/24/2013SCM       
AP08/19/2013SLR36835047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018983s047lbl.pdf 8/19/2013
AP08/19/2013SLR36868047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018983Orig1s047ltr.pdf 8/22/2013




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