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FDA Drug Application 019353 by AKORN

Application Number019353
Application Type New Drug Application
Sponsor ApplicantAKORN
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
AP012/29/1986N       
AP07/28/1988SLR       
AP07/5/1990SCS       
AP012/6/1990SCS       
AP08/7/1991SCS       
AP01/7/1994SCP       
AP01/7/1994SCM       
AP011/10/1992SCM       
AP011/22/1993SE1       
AP08/18/1994SCS       
AP08/3/1995SCM       
AP02/22/1995SCM       
AP010/30/1995SLR       
AP01/28/1997SCM       
AP01/20/1998SCS       
AP05/25/1999SCS       
AP07/24/2015SLR43494019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019353Orig1s019ltr.pdf 7/27/2015
AP07/24/2015SLR43545019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf 7/30/2015




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