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FDA Drug Application 019050 by AKORN

Application Number019050
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/4/1984N       
AP09/10/1984SCS       
AP08/21/1985SCS       
AP08/21/1985SLR       
AP06/20/1986SCS       
AP03/18/1986SLR       
AP03/18/1986SCS       
AP08/6/1986SCS       
AP011/14/1986SCM       
AP011/14/1986SLR       
AP04/29/1987SCE       
AP010/5/1990SCS       
AP03/19/1993SE3       
AP03/23/1994SCS       
AP03/23/1994SCP       
AP03/23/1994SCM       
AP011/10/1992SCM       
AP02/22/1995SCM       
AP08/12/1997SCS       
AP06/21/1996SLR       
AP08/27/2001SLR       
AP05/1/1998SCM       
AP05/26/1998SCS       
AP05/25/1999SCS       
AP06/4/2007SLR16714031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019050s031ltr.pdf 6/7/2007
AP06/4/2007SLR16720031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019050s031lbl.pdf 6/7/2007
AP03/20/2014SLR38870032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019050Orig1s032ltr.pdf 3/21/2014
AP03/20/2014SLR38886032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf 3/25/2014




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