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FDA Drug Application 019872 by J AND J CONSUMER INC

Application Number019872
Application Type New Drug Application
Sponsor ApplicantJ AND J CONSUMER INC
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
AP06/8/1994N       
AP011/23/1994SCP       
AP07/28/1995SCP       
AP01/5/1995SCS       
AP08/1/1995SCS       
AP01/11/2001SCF32420006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019872Orig1s006.pdf 4/13/2012
AP07/25/2000SLR33045009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019872Orig1s009.pdf 6/28/2012
AP07/25/2000SCP       
AP02/12/2001SCM       
AP05/29/2003SLR5802012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr012ltr.pdf 6/8/2003
AP05/29/2003SLR5875012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf 6/8/2003
AP05/28/2003SLR5803013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr013ltr.pdf 6/8/2003
AP05/28/2003SLR5876013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf 6/8/2003
AP05/28/2003SLR5804014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr014ltr.pdf 6/8/2003
AP05/28/2003SLR5877014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf 6/8/2003
AP08/1/2003SCS6491016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872scs016ltr.pdf 8/14/2003
AP03/22/2004SCP8160017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872scp017ltr.pdf 3/30/2004
AP04/13/2004SLR8379018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872slr018ltr.pdf 4/20/2004
AP011/3/2004SCP10540021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872s021ltr.pdf 11/8/2004
AP02/28/2008SLR31535029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019872Orig1_s029.pdf 1/27/2012
AP06/17/2009SLR22803031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019872s031ltr.pdf 6/23/2009
AP06/17/2009SLR22842031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019872s031Lbl.pdf 6/29/2009
AP05/6/2010SLR25524033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019872s033ltr.pdf 5/12/2010
AP05/10/2010SCM25549034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019872s034ltr.pdf 5/17/2010
AP012/23/2011SLR31314036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019872s36ltr.pdf 1/3/2012
AP012/23/2011SLR38237036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019872Orig1s036lbl.pdf 1/9/2014
AP03/26/2013SLR35557037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019872Orig1s037ltr.pdf 3/28/2013
AP03/26/2013SLR38238037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s037lbl.pdf 1/9/2014
AP03/28/2013SCM       
AP012/20/2013SLR38186039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019872Orig1s039ltr.pdf 12/26/2013
AP012/20/2013SLR38239039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf 1/9/2014
AP03/6/2014SLR38716040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s040ltr.pdf 3/7/2014
AP03/6/2014SLR38918040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s040lbl.pdf 3/27/2014
AP012/12/2014SLR41250041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s041ltr.pdf 12/15/2014
AP012/12/2014SLR41255041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s041lbl.pdf 12/15/2014
AP012/23/2014SLR41439042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s042ltr.pdf 12/30/2014
AP012/23/2014SLR41493042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s042lbl.pdf 1/5/2015
AP05/5/2016SCM       
AP08/26/2016SLR46920044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019872Orig1s044lbl.pdf 8/30/2016
AP08/26/2016SLR46925044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019872Orig1s044ltr.pdf 8/30/2016
AP08/15/2016SCM       




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