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FDA Drug Application 020538 by NOVARTIS

Application Number020538
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/31/1996N       
AP09/15/1997SCS       
AP09/15/1997SCS       
AP09/23/1997SCS       
AP09/25/1997SCS       
AP09/26/1997SCM       
AP01/8/1999SCF642006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538S6.cfm 1/8/1999
AP01/8/1999SCF4713006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_appltr.pdf 1/8/1999
AP01/8/1999SCF4714006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_prntlbl.pdf 1/8/1999
AP07/30/1999SCS       
AP03/26/1999SLR       
AP010/29/1999SCS       
AP09/29/2000SCS       
AP05/3/2002SLR4870012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf 5/3/2002
AP05/3/2002SLR4871012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf 5/3/2002
AP07/9/2001SCM       
AP05/3/2002SE84872014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf 5/3/2002
AP05/3/2002SE84873014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf 5/3/2002
AP05/3/2002SE14874015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf 5/3/2002
AP05/3/2002SE14875015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf 5/3/2002
AP05/3/2002SE114117015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020538_s015_VivelleTOC.cfm 5/16/2006
AP02/22/2002SCS       
AP03/28/2002SCS       
AP01/28/2004SLR7645019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20538slr019ltr.pdf 2/2/2004
AP01/28/2004SLR7658019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538slr019_vivelle_lbl.pdf 2/3/2004
AP08/6/2004SLR9980024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20538s024ltr.pdf 8/10/2004
AP08/6/2004SLR9985024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538s024lbl.pdf 8/10/2004
AP05/16/2013SLR36090028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf 5/21/2013
AP05/16/2013SLR36100028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf 5/21/2013
AP05/16/2013SLR36091029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf 5/21/2013
AP05/16/2013SLR36101029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf 5/21/2013
AP05/16/2013SLR36092030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf 5/21/2013
AP05/16/2013SLR36102030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf 5/21/2013
AP04/24/2013SCM       
AP07/31/2014SLR40106032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020538Orig1s032ltr.pdf 8/1/2014
AP07/31/2014SLR40111032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020538s032lbl.pdf 8/1/2014
AP09/1/2015SCM       
AP08/29/2016SCM       




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