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FDA Drug Application 020037 by NOVARTIS

Application Number020037
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/28/1991N       
AP01/9/1992SLR       
AP012/8/1992SCP       
AP03/15/1995SCM       
AP03/15/1995SCP       
AP05/3/1995SLR       
AP011/19/1997SCP       
AP07/23/1996SE1       
AP02/25/1998SE1       
AP08/5/1998SCS       
AP010/27/2000SCM       
AP012/26/2000SCS       
AP09/4/2007SLR17746014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020037s014lbl.pdf 9/6/2007
AP09/4/2007SLR17767014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020037s014ltr.pdf 9/6/2007
AP010/12/2001SCS       
AP04/9/2002SCS       
AP010/1/2002SCS       
AP04/8/2011SLR28507023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020037s023lbl.pdf 4/11/2011
AP04/8/2011SLR28534023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020037s023ltr.pdf 4/13/2011
AP09/13/2012SLR33751031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020037Orig1s031ltr.pdf 9/14/2012
AP09/13/2012SLR33757031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020037s031lbl.pdf 9/14/2012




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