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FDA Drug Application 019057 by ABBOTT

Application Number019057
Application Type New Drug Application
Sponsor ApplicantABBOTT
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
AP08/7/1987N       
AP07/1/1988SLR       
AP09/20/1988SCS       
AP08/10/1990SLR       
AP08/9/1991SCS       
AP08/20/1993SCS       
AP09/29/1993SLR       
AP06/17/1994SCS       
AP09/14/1994SLR       
AP010/6/1995SCM       
AP07/11/1995SCS       
AP09/18/1996SLR       
AP08/8/1996SCS       
AP04/16/1998SCP       
AP08/6/1998SCS       
AP01/23/2002SLR2281015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19057s15ltr.pdf 1/23/2002
AP01/23/2002SLR7469015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-057-S015.pdf 1/6/2004
AP010/4/2002SCS       
AP011/15/2002SCS       
AP012/24/2002SCS       
AP02/6/2006SLR13611021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019057Orig1s021,020347Orig1s009 ltr.pdf 2/8/2006
AP02/6/2006SLR45647021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf 4/11/2016
AP07/10/2009SLR22977022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019057s022ltr.pdf 7/16/2009
AP07/10/2009SLR23043022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019057s022lbl.pdf 7/23/2009




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