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FDA Drug Application 022578 by J AND J CONSUMER INC

Application Number022578
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
AP09/3/2010N26422000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022578s000ltr.pdf 9/8/2010
AP09/3/2010N27601000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022578s000_zyrtec_allergy_toc.cfm 1/25/2011
AP09/3/2010N27895000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022578Orig1s000SumR.pdf 2/17/2011
AP012/1/2011SLR30880001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022578s001ltr.pdf 12/5/2011
AP02/24/2014SCM       
AP02/21/2014SCM       
AP08/1/2016SCM       
AP08/23/2016SLR46880007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022578Orig1s007ltr.pdf 8/25/2016
AP08/23/2016SLR46915007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022578Orig1s007lbl.pdf 8/30/2016




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