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FDA Drug Application 018874 by ABBVIE

Application Number018874
Application Type New Drug Application
Sponsor ApplicantABBVIE
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
AP09/25/1986N       
AP07/25/1991SCS       
AP04/4/1990SLR       
AP010/31/1995SCS       
AP01/5/1996SCS       
AP010/22/1996SE2       
AP06/10/1997SLR       
AP012/31/1997SLR       
AP04/4/2000SLR       
AP05/26/1999SCS       
AP012/2/1999SLR       
AP09/15/2000SCS       
AP01/29/2001SCE       
AP05/7/2001SCS       
AP011/16/2001SE86215016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18874s16ltr.pdf 7/30/2003
AP07/1/2007SLR16932019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018874s019_ltr.pdf 7/5/2007
AP03/9/2012SLR32105022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018874s022ltr.pdf 3/14/2012
AP03/9/2012SLR32206022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018874s022lbl.pdf 3/27/2012




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