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FDA Drug Application 019599 by MERZ PHARMS

Application Number019599
Application Type New Drug Application
Sponsor ApplicantMERZ 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
AP02/29/1988N       
AP04/5/1989SE1       
AP07/5/1990SE2       
AP01/30/1990SCS       
AP06/15/1995SCP       
AP09/24/1997SCS       
AP011/30/1998SCM       
AP06/4/2002SCM44391007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019599Orig1s007.pdf 11/5/2015
AP01/26/2009SCP21696010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019599s010ltr.pdf 1/30/2009
AP01/13/2012SE231407011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019599s011ltr.pdf 1/18/2012
AP01/13/2012SE231470011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019599s011lbl.pdf 1/23/2012
AP010/10/2014SE840765012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019599Orig1s012ltr.pdf 10/14/2014
AP010/10/2014SE840790012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019599s012lbledt.pdf 10/15/2014




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