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FDA Drug Application 011792 by MEDA PHARMS

Application Number011792
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/9/1959N       
AP012/13/1974SCS       
AP07/19/1974SDS       
AP011/8/1974SDS       
AP05/20/1975SLR       
AP012/5/1979SCF       
AP011/30/1979SCS       
AP04/13/1979SCM       
AP010/27/1981SCM       
AP03/18/1983SCM       
AP03/18/1983SCS       
AP04/19/1983SCS       
AP011/27/1987SCF       
AP04/30/1986SCP       
AP010/27/1986SLR       
AP09/1/1987SCS       
AP011/10/1987SCP       
AP03/2/1994SCS       
AP010/25/1993SCS       
AP06/8/2006SLR14289035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011792s035LTR.pdf 6/12/2006
AP06/8/2006SLR14294035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011792s035lbl.pdf 6/12/2006
AP012/29/1999SCP       
AP09/13/2007SE217894041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011792s041lbl.pdf 9/19/2007
AP09/13/2007SE217941041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011792s041ltr.pdf 9/25/2007
AP09/13/2007SE234402041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/011792Orig1s041.pdf 11/16/2012
AP011/17/2009SLR23928043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011792s043lbl.pdf 11/17/2009
AP011/17/2009SLR24449043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011792s043ltr.pdf 1/6/2010
AP02/1/2013SLR35057045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/011792Orig1s045ltr.pdf 2/4/2013
AP02/1/2013SLR35078045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/011792s045lbl.pdf 2/6/2013
AP02/23/2015SLR41912046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011792Orig1s046ltr.pdf 2/25/2015




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