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FDA Drug Application 021278 by NOVARTIS

Application Number021278
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
AP011/13/2001N1666000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin.cfm 11/13/2001
AP011/13/2001N4672000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_Approv.pdf 11/13/2001
AP011/13/2001N4673000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_prntlbl.pdf 11/13/2001
AP011/13/2001N16554000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 5/10/2007
AP011/13/2001N23713000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088600.pdf 10/30/2009
AP01/3/2002SLR       
AP08/24/2006SLR14761004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf 8/29/2006
AP08/24/2006SLR14877004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021278s004, s005ltr.pdf 9/18/2006
AP08/24/2006SLR14878005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021278s004, s005ltr.pdf 9/18/2006
AP08/24/2006SLR14762005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf 8/29/2006
AP03/8/2007SLR16029007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s007ltr.pdf 3/15/2007
AP03/8/2007SLR16041007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s007lbl.pdf 3/15/2007
AP04/25/2007SLR16356008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf 5/1/2007
AP04/25/2007SLR16391008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s008,021802s009ltr.pdf 5/1/2007
AP011/15/2010SLR26991012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s012lbl.pdf 11/19/2010
AP011/15/2010SLR26993012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s021,021278s012ltr.pdf 11/22/2010
AP012/9/2010SLR27274013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s013lbl.pdf 12/10/2010
AP012/9/2010SLR27287013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf 12/15/2010
AP05/2/2012SLR32618015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021802s024,021278s015ltr.pdf 5/4/2012
AP05/2/2012SLR32624015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021278s015lbl.pdf 5/7/2012
AP06/11/2013SLR36282016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021802Orig1s025,021278Orig1s016ltr.pdf 6/12/2013
AP06/11/2013SLR36318016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s016lbl.pdf 6/18/2013
AP012/12/2013SLR38039017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021278Orig1s017,021802Orig1s026ltr.pdf 12/13/2013
AP012/12/2013SLR38055017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s017lbl.pdf 12/17/2013
AP04/17/2015SLR42577018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021278Orig1s018,021802Orig1s028ltr.pdf 4/20/2015
AP04/17/2015SLR42608018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf 4/21/2015
AP012/4/2015SCM       
AP05/13/2016SCM       




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