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FDA Drug Application 012365 by MEDA PHARMS

Application Number012365
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
AP09/12/1960N       
AP012/12/1974SCS       
AP07/19/1974SDS       
AP012/12/1974SDS       
AP02/15/1980SLR       
AP010/29/1981SCM       
AP03/11/1983SCF       
AP04/5/1983SCM       
AP04/5/1983SCS       
AP04/19/1983SCS       
AP07/11/1983SCF       
AP01/10/1986SLR       
AP09/30/1986SCP       
AP010/25/1993SCS       
AP04/1/2009SLR22202035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012365s035ltr.pdf 4/3/2009
AP04/1/2009SLR22211035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s035lbl.pdf 4/3/2009
AP03/2/2000SCP       
AP011/17/2009SLR23927038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012365s038lbl.pdf 11/17/2009
AP011/17/2009SLR24450038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012365s038ltr.pdf 1/6/2010
AP01/31/2013SLR35046039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012365s039lbl.pdf 2/1/2013
AP01/31/2013SLR35052039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012365s039,012366s033ltr.pdf 2/4/2013




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