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FDA Drug Application 016619 by AKORN

Application Number016619
Application Type New Drug Application
Sponsor ApplicantAKORN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/19/1968N       
AP011/8/1976SLR       
AP05/23/1980SCS       
AP02/24/1981SCS       
AP02/24/1981SLR       
AP07/7/1982SCS       
AP07/7/1982SLR       
AP03/11/1983SCM       
AP09/7/1983SCS       
AP09/10/1985SPD       
AP09/5/1986SCS       
AP09/5/1986SLR       
AP01/27/1987SLR       
AP011/25/1991SCS       
AP09/14/1989SCM       
AP07/5/1990SCS       
AP012/7/1992SCS       
AP010/28/1992SCM       
AP012/23/1993SCS       
AP012/23/1993SCM       
AP012/23/1993SCP       
AP012/23/1993SLR       
AP02/22/1995SCM       
AP04/26/1996SLR       
AP010/17/2003SLR6830032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16619slr032ltr.pdf 10/22/2003
AP07/3/2013SLR36471034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016619s034lbl.pdf 7/5/2013
AP07/3/2013SLR36496034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016619Orig1s034ltr.pdf 7/8/2013
AP05/18/2016SCM       




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