Back to FDA Applications sponsored by NOVARTIS

FDA Drug Application 020831 by NOVARTIS

Application Number020831
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP02/16/2001N331000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil.cfm 2/16/2001
AP02/16/2001N4720000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil_approv.pdf 2/16/2001
AP02/16/2001N4721000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20831_Foradil_prntlbl.pdf 2/16/2001
AP02/16/2001N7115000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm 12/9/2003
AP02/16/2001N23996000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088602.pdf 11/19/2009
AP04/25/2001SCS       
AP09/25/2001SLR17158002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020831_S002_FORADIL_AP.pdf 7/9/2007
AP09/25/2001SLR9037002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21279ltr.pdf 6/4/2004
AP09/25/2001SLR5450002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20831s2lbl.pdf 4/24/2003
AP011/21/2001SCM       
AP05/17/2002SCM       
AP06/27/2003SE56056005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20831se5-005ltr.pdf 7/6/2003
AP06/27/2003SE56084005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20831se5-005_foradil_lbl.pdf 7/8/2003
AP06/19/2006SLR14319009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020831s009lbl.pdf 6/20/2006
AP06/19/2006SLR14329009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020831s009LTR.pdf 6/20/2006
AP06/2/2010SLR25667021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020831s021lbl.pdf 6/2/2010
AP06/2/2010SLR25680021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020831s021,021592s003ltr.pdf 6/3/2010
AP05/18/2011SLR28925022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s022ltr.pdf 5/25/2011
AP02/9/2011SLR27821024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020831s024MedG.pdf 2/11/2011
AP02/9/2011SLR27824024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s024ltr.pdf 2/14/2011
AP05/3/2011SLR28709025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020831s025lbl.pdf 5/5/2011
AP05/3/2011SLR28728025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020831s025ltr.pdf 5/6/2011
AP03/20/2012SLR32174027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s027lbl.pdf 3/23/2012
AP03/20/2012SLR32175027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s027mg.pdf 3/23/2012
AP03/20/2012SLR32180027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020831s027ltr.pdf 3/26/2012
AP09/27/2012SLR33872028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s028lbl.pdf 9/28/2012
AP09/27/2012SLR33904028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020831Orig1s028ltr.pdf 10/2/2012
AP03/29/2013SLR35591029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020831s029,s032ltr.pdf 4/1/2013
AP02/8/2013SCM       
AP04/17/2013SCM       
AP03/29/2013SLR35592032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020831s029,s032ltr.pdf 4/1/2013
AP012/13/2013SCM       
AP03/2/2016SCM       




Back to FDA Applications sponsored by NOVARTIS

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.