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FDA Drug Application 020539 by NOVARTIS

Application Number020539
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
AP05/10/1996N2664000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf 5/3/2001
AP012/6/1996SCS       
AP010/4/1996SCM       
AP01/5/1999SE8       
AP04/21/1999SCP       
AP02/1/2000SCM       
AP04/30/2001SCS       
AP04/13/2001SLR1624010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf 4/13/2001
AP012/27/2001SCM       
AP01/21/2004SLR7644012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20539slr012ltr.pdf 2/2/2004
AP01/21/2004SLR7659012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20539slr012_lamisil_lbl.pdf 2/3/2004
AP012/2/2010SLR27163017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020539s017lbl.pdf 12/4/2010
AP012/2/2010SLR27195017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020539s017ltr.pdf 12/6/2010
AP03/30/2011SLR28408018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s018ltr.pdf 3/31/2011
AP03/30/2011SLR28429018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s018lbl.pdf 4/1/2011
AP011/4/2011SLR30537020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s020ltr.pdf 11/8/2011
AP011/4/2011SLR32166020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s020lbl.pdf 3/22/2012
AP04/23/2012SLR32542021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020539s021ltr.pdf 4/27/2012
AP04/23/2012SLR32596021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020539s021lbl.pdf 5/2/2012
AP06/17/2013SLR36308023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s023lbl.pdf 6/17/2013
AP06/17/2013SLR36339023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s023ltr.pdf 6/18/2013
AP010/23/2013SLR37559024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s024ltr.pdf 10/25/2013
AP010/23/2013SLR37585024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s024lbl.pdf 10/25/2013
AP02/12/2016SCM       
AP08/23/2016SLR46883026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020539Orig1s026ltr.pdf 8/25/2016
AP08/23/2016SLR47181026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020539s026lbl.pdf 9/28/2016




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