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FDA Drug Application 021121 by JANSSEN PHARMS

Application Number021121
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP08/1/2000N1249000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21121ltr.pdf 8/1/2000
AP08/1/2000N1250000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-121_Concerta.cfm 8/1/2000
AP08/1/2000N1251000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21121lbl.pdf 8/1/2000
AP08/1/2000N16553000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 5/10/2007
AP08/1/2000N23917000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088575.pdf 11/16/2009
AP012/8/2000SCM       
AP04/26/2001SLR       
AP03/4/2002SCM       
AP04/1/2002SCM16822004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021121_S004_CONCERTA_AP.pdf 6/22/2007
AP04/1/2002SCM2562004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21121s4ltr.pdf 4/1/2002
AP012/18/2002SCM       
AP010/21/2004SE110496008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21121s008ltr.pdf 10/29/2004
AP010/21/2004SE110520008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21121s008lbl.pdf 11/1/2004
AP09/7/2006SLR14805009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021121s009s012lbl.pdf 9/12/2006
AP09/7/2006SLR14841009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021121s009,s012_ltr.pdf 9/18/2006
AP09/7/2006SLR14842012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021121s009,s012_ltr.pdf 9/18/2006
AP09/7/2006SLR14806012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021121s009s012lbl.pdf 9/12/2006
AP05/3/2007SLR16444014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021121s014lbl.pdf 5/7/2007
AP05/3/2007SLR16488014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021121s014ltr.pdf 5/9/2007
AP06/27/2008SLR20111015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf 6/30/2008
AP06/27/2008SLR20144015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021121s015, 021121se5-017ltr.pdf 7/1/2008
AP06/27/2008SE520112017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021121s015s017lbl.pdf 6/30/2008
AP06/27/2008SE520143017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021121s015, 021121se5-017ltr.pdf 7/1/2008
AP06/27/2008SE530058017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021121s017.pdf 9/22/2011
AP011/4/2009SE824095022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021121s022lbl.pdf 11/23/2009
AP011/4/2009SE824607022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021121s022ltr.pdf 1/25/2010
AP011/23/2010SLR27091026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021121s026,021121s027ltr.pdf 11/30/2010
AP011/23/2010SLR27122026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf 12/1/2010
AP011/23/2010SLR27124026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027MedG.pdf 12/1/2010
AP011/23/2010SLR27125027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027MedG.pdf 12/1/2010
AP011/23/2010SLR27123027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021121s026s027lbl.pdf 12/1/2010
AP011/23/2010SLR27092027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021121s026,021121s027ltr.pdf 11/30/2010
AP05/3/2013SLR35952029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021121Orig1s029ltr.pdf 5/7/2013
AP05/3/2013SLR35998029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s029lbl.pdf 5/9/2013
AP07/30/2013SCM       
AP06/12/2013SLR36292031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021121Orig1s031ltr.pdf 6/14/2013
AP06/12/2013SLR36314031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s031lbl.pdf 6/18/2013
AP012/12/2013SLR38044032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021121Orig1s032ltr.pdf 12/16/2013
AP012/12/2013SLR38051032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021121s032lbl.pdf 12/17/2013
AP08/11/2014SCM       
AP04/17/2015SLR42587035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021121Orig1s035ltr.pdf 4/21/2015
AP04/17/2015SLR42623035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021121s035lbl.pdf 4/22/2015




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