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FDA Drug Application 019081 by NOVARTIS

Application Number019081
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP09/10/1986N       
AP012/3/1986SCS       
AP02/26/1987SLR       
AP01/7/1988SCM       
AP01/7/1988SCM       
AP01/7/1988SCM       
AP01/7/1988SCM       
AP07/7/1987SLR       
AP04/28/1988SLR       
AP05/25/1988SCP       
AP07/1/1988SCS       
AP02/3/1989SCM       
AP01/19/1990SCF       
AP06/18/1990SCS       
AP06/19/1990SLR       
AP06/12/1990SCM       
AP010/24/1991SE1       
AP01/22/1992SCS       
AP09/22/1995SLR       
AP08/9/1993SCS       
AP04/5/1993SLR       
AP05/18/1994SCF       
AP02/10/1995SCF       
AP01/20/1995SCM       
AP011/28/1995SLR       
AP012/7/1995SLR       
AP06/27/1996SCS       
AP06/27/1996SCS       
AP012/10/1997SLR       
AP08/20/2001SCM       
AP03/14/2002SCM       
AP05/28/2004SLR8850036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf 6/1/2004
AP05/28/2004SLR8872036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081slr036,039ltr.pdf 6/1/2004
AP05/28/2004SLR20422036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019081_s036&s039_ESTRADERM.pdf 8/1/2008
AP05/28/2004SLR20423039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019081_s036&s039_ESTRADERM.pdf 8/1/2008
AP05/28/2004SLR8873039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081slr036,039ltr.pdf 6/1/2004
AP05/28/2004SLR8851039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf 6/1/2004
AP012/17/2004SLR10863040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081s040ltr.pdf 12/30/2004
AP012/17/2004SLR10895040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081s040lbl.pdf 12/30/2004
AP07/3/2012SLR33081042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019081s042ltr.pdf 7/9/2012
AP07/3/2012SLR33196042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019081s042lbl.pdf 7/13/2012




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