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FDA Drug Application 022155 by J AND J CONSUMER INC

Application Number022155
Application Type New Drug Application
Sponsor ApplicantJ AND J CONSUMER INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/16/2007N18576000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022155s000ltr_CKD.pdf 11/26/2007
AP011/16/2007N19864000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022155s000TOC.cfm 5/21/2008
AP08/14/2008SLR20618002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s002ltr.pdf 8/19/2008
AP08/14/2008SCF20617003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s003ltr.pdf 8/19/2008
AP03/4/2009SCF21961005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s005ltr.pdf 3/5/2009
AP03/13/2009SCP22008006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s006ltr.pdf 3/17/2009
AP05/22/2012SLR32760007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022155s007ltr.pdf 5/24/2012
AP05/16/2014SLR39326009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.pdf 5/19/2014
AP05/16/2014SLR39330009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022155Orig1s009ltr.pdf 5/20/2014
AP04/14/2016SCM45692010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022155Orig1s010ltr.pdf 4/18/2016
AP04/14/2016SCM45705010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022155Orig1s010lbl.pdf 4/20/2016
AP09/10/2015SCM       




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