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FDA Drug Application 017078 by AMEDRA PHARMS

Application Number017078
Application Type New Drug Application
Sponsor ApplicantAMEDRA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/2/1976N16582000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 5/18/2007
AP08/2/1976N23948000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088583.pdf 11/18/2009
AP03/30/1979SLR       
AP03/30/1979SLR       
AP06/6/1979SLR       
AP06/27/1979SLR       
AP08/30/1979SLR       
AP04/16/1980SLR       
AP08/29/1980SLR       
AP08/29/1980SLR       
AP08/29/1980SLR       
AP09/19/1980SLR       
AP010/6/1980SLR       
AP02/22/1983SLR       
AP08/25/1982SLR       
AP08/25/1982SLR       
AP012/2/1987SLR       
AP012/16/1987SLR       
AP07/21/1993SLR       
AP09/12/1994SLR       
AP07/9/1997SLR       
AP04/6/1998SCF       
AP04/6/1998SCM       
AP06/12/1998SCS       
AP012/3/1998SCM       
AP011/3/1999SLR       
AP010/7/1999SCM       
AP010/7/1999SCF       
AP04/13/2000SCM       
AP010/20/2000SCS       
AP08/10/2006SLR14658040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf 8/11/2006
AP08/10/2006SLR14706040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017078s040LTR.pdf 8/14/2006
AP05/1/2007SLR16437042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017078s042ltr.pdf 5/7/2007
AP05/1/2007SLR16452042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017078s042lbl.pdf 5/7/2007
AP05/23/2008SLR19878044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017078s044ltr.pdf 5/28/2008
AP05/23/2008SLR19991044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017078s044lbl.pdf 6/12/2008
AP06/11/2013SLR36284046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017078Orig1s046ltr.pdf 6/13/2013
AP06/11/2013SLR36317046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf 6/18/2013
AP012/6/2013SLR37992047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017078Orig1s047ltr.pdf 12/10/2013
AP012/6/2013SLR38014047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf 12/12/2013
AP04/17/2015SLR42572048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf 4/20/2015
AP04/17/2015SLR42584048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017078Orig1s048ltr.pdf 4/20/2015




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