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FDA Drug Application 021284 by NOVARTIS

Application Number021284
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
AP06/5/2002N3215000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21284lbl.pdf 6/5/2002
AP06/5/2002N3216000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21284ltr.pdf 6/5/2002
AP06/5/2002N3217000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-284_Ritalin.cfm 11/20/2002
AP06/5/2002N16558000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 5/10/2007
AP06/5/2002N24071000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089092.pdf 11/20/2009
AP012/10/2002SCS       
AP04/8/2004SCM8357004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21284scm004ltr.pdf 4/20/2004
AP08/8/2006SLR14644006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf 8/9/2006
AP08/8/2006SLR14675006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf 8/11/2006
AP08/8/2006SLR14645008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf 8/9/2006
AP08/8/2006SLR14676008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf 8/11/2006
AP04/27/2010SLR25386010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021284s010ltr.pdf 4/29/2010
AP04/27/2010SLR25502010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s010lbl.pdf 5/7/2010
AP04/27/2010SLR25503010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s010MedGuide.pdf 5/7/2010
AP04/25/2007SLR16352011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf 5/1/2007
AP04/25/2007SLR16394011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010187s069,018029s040,021284s011ltr.pdf 5/1/2007
AP011/15/2010SLR26971017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s017Medguide.pdf 11/17/2010
AP011/15/2010SLR26972017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s017lbl.pdf 11/17/2010
AP011/15/2010SLR26984017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010187s072,018029s042,021284s017ltr.pdf 11/18/2010
AP012/9/2010SLR27273018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s018lbl.pdf 12/10/2010
AP012/9/2010SLR27289018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf 12/15/2010
AP06/7/2013SLR36255019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s074,018029Orig1s044,021284Orig1s019ltr.pdf 6/11/2013
AP06/7/2013SLR36261019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021284s019lbl.pdf 6/11/2013
AP05/6/2013SLR35944020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021284s020lbl.pdf 5/6/2013
AP05/6/2013SLR35967020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021284Orig1s020ltr.pdf 5/7/2013
AP010/25/2013SCM       
AP012/13/2013SLR38050023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029Orig1s047,021284Orig1s023ltr.pdf 12/16/2013
AP012/13/2013SLR38060023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021284s023lbl.pdf 12/17/2013
AP010/27/2014SCM40973025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021284Orig1s025ltr.pdf 11/10/2014
AP010/27/2014SCM41313025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021284Orig1s025lbl.pdf 12/19/2014
AP06/2/2015SCM       
AP04/17/2015SLR42590027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010187Orig1s080,018029Orig1s049,021284Orig1s027ltr.pdf 4/21/2015
AP04/17/2015SLR42603027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf 4/21/2015
AP02/9/2016SCM       




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