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FDA Drug Application 012366 by MEDA PHARMS

Application Number012366
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
AP010/5/1960N       
AP07/19/1974SDS       
AP011/16/1981SLR       
AP011/16/1981SCM       
AP010/29/1981SCM       
AP02/23/1982SLR       
AP04/5/1983SCM       
AP04/5/1983SCS       
AP04/19/1983SCS       
AP07/11/1983SCF       
AP02/23/1984SCE       
AP01/16/1986SLR       
AP010/22/1993SCS       
AP04/15/1998SCE       
AP06/22/2001SCS       
AP03/2/2000SCP       
AP010/23/2008SLR21085031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/012366s031ltr.pdf 10/28/2008
AP010/23/2008SLR21144031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012366s031lbl.pdf 11/7/2008
AP011/6/2009SLR23909032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012366s032lbl.pdf 11/16/2009
AP011/6/2009SLR24451032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012366s032ltr.pdf 1/6/2010
AP01/31/2013SLR35045033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s033lbl.pdf 2/1/2013
AP01/31/2013SLR35053033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012365s039,012366s033ltr.pdf 2/4/2013
AP05/9/2013SLR36037034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012366Orig1s034ltr.pdf 5/13/2013
AP05/9/2013SLR36055034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012366s034lbl.pdf 5/14/2013




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