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FDA Drug Application 009175 by CASPER PHARMA LLC

Application Number009175
Application Type New Drug Application
Sponsor ApplicantCASPER PHARMA LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1953N       
AP011/23/1973S       
AP01/3/1978SCM       
AP012/17/1979SLR       
AP06/12/1987SLR       
AP011/18/1982SLR       
AP05/18/1993SE1       
AP06/12/1987SLR       
AP05/13/1988SLR14083019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm 5/10/2006
AP02/11/1999SLR       
AP08/9/1993SCS       
AP04/7/1998SLR       
AP03/27/1997SLR       
AP010/15/1996SCE       
AP012/3/1998SCP       
AP08/25/1999SLR       
AP05/30/2008SLR19922033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/009175s033ltr.pdf 6/3/2008
AP011/4/2013SLR37685036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/009175s036lbl.pdf 11/4/2013
AP011/4/2013SLR37723036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/009175Orig1s036ltr.pdf 11/7/2013
AP02/6/2009SLR21801037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009175s037lbl.pdf 2/10/2009
AP02/6/2009SLR21836037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009175s037ltr.pdf 2/13/2009
AP010/27/2010SLR26849038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009175s038ltr.pdf 11/2/2010
AP010/27/2010SLR45457038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009175s038lbl.pdf 3/18/2016
AP010/14/2010SLR26675039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009175s039ltr.pdf 10/19/2010
AP011/3/2014SCM       
AP07/11/2016SCM       




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