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FDA Drug Application 020726 by NOVARTIS PHARMS

Application Number020726
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS
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
AP07/25/1997N6417000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020726_femara_toc.cfm 8/7/2003
AP03/17/1999SCM       
AP04/22/1999SCP       
AP02/5/2001SCS       
AP05/23/2000SCM       
AP02/26/2003SE84254005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726se8-005ltr.pdf 3/10/2003
AP02/26/2003SE84050005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s005lbl.pdf 3/4/2003
AP01/10/2001SE11581006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20726S006LTR.PDF 1/10/2001
AP01/10/2001SE11582006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20726S006LBL.PDF 1/10/2001
AP01/10/2001SE11844006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-726S006_Femara.cfm 1/10/2001
AP01/10/2002SCM       
AP01/17/2003SE84207008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020726s008lbl.pdf 1/17/2003
AP01/17/2003SE89001008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20726s8ltr.pdf 6/4/2004
AP010/29/2004SE110509011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020726s011lbl.pdf 10/29/2004
AP010/29/2004SE111028011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20726s011ltr.pdf 1/26/2005
AP012/28/2005SE113338012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020726s012lbl.pdf 1/5/2006
AP012/28/2005SE113356012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020726s012rev2.pdf 1/6/2006
AP06/26/2006SLR14353013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020726s013LTR.pdf 6/27/2006
AP04/11/2007SLR16249014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020726s014LTR.pdf 4/20/2007
AP04/11/2007SLR16278014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020726s014lbl.pdf 4/20/2007
AP03/2/2010SE824992015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf 3/8/2010
AP03/2/2010SE824919015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf 3/3/2010
AP03/2/2010SE824920016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s015s016lbl.pdf 3/3/2010
AP03/2/2010SE824993016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s015s016ltr.pdf 3/8/2010
AP08/7/2008SLR20602017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020726s017ltr.pdf 8/13/2008
AP07/7/2009SLR22926018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020726s018lbl.pdf 7/9/2009
AP07/7/2009SLR22984018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020726s018ltr.pdf 7/17/2009
AP06/25/2010SLR25830019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s019ltr.pdf 6/29/2010
AP06/25/2010SLR25892019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s019lbl.pdf 7/1/2010
AP04/30/2010SE725465020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020726s020ltr.pdf 5/6/2010
AP04/30/2010SE725470020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020726s020lbl.pdf 5/6/2010
AP012/23/2011N31243024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020726s024lbl.pdf 12/23/2011
AP012/23/2011N31312024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020726s024ltr.pdf 1/3/2012
AP07/11/2013SCM       
AP01/15/2014SLR38297027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020726s027lbl.pdf 1/16/2014
AP01/15/2014SLR38311027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020726Orig1s027ltr.pdf 1/17/2014
AP012/23/2015SCM       




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