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FDA Drug Application 019710 by LIEBEL-FLARSHEIM

Application Number019710
Application Type New Drug Application
Sponsor ApplicantLIEBEL-FLARSHEIM
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
AP012/30/1988N       
AP04/17/1989SLR       
AP010/10/1989SCP       
AP03/30/1990SCS       
AP01/22/1992SE1       
AP01/22/1992SCS       
AP07/9/1992SE1       
AP012/4/1992SCS       
AP08/28/1992SCP       
AP09/22/1993SCM       
AP010/26/1992SCM       
AP012/11/1992SE1       
AP07/12/1996SCP       
AP03/9/1993SE1       
AP07/27/1993SE1       
AP06/21/1995SE1       
AP01/13/1995SLR       
AP05/23/1997SCM4317021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019710a_so21_052397.pdf 5/23/1997
AP03/25/1999SCM       
AP04/16/1999SCM       
AP010/27/1999SCF       
AP01/23/2001SCP       
AP09/12/2001SCM       
AP08/2/2001SCS       
AP04/25/2008SLR19739032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s032ltr.pdf 4/28/2008
AP04/25/2008SLR19749034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s034ltr.pdf 4/30/2008
AP08/8/2009SLR       
AP18/12/2016SLR46788039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf 8/17/2016
AP18/12/2016SLR46799039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019710Orig1s039,020923Orig1s009ltr.pdf 8/18/2016
AP012/19/2013SCM       
AP012/6/2013SCM       
AP07/6/2015SLR43297052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf 7/9/2015
AP07/6/2015SLR43321052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019710Orig1s052,020923Orig1s018ltr.pdf 7/10/2015
AP05/13/2016SCM       




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