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FDA Drug Application 021952 by BAYER HEALTHCARE LLC

Application Number021952
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
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
AP06/16/2008N20031000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021952s000ltr.pdf 6/19/2008
AP06/16/2008N20246000   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021952s000_SUMR.pdf 7/17/2008
AP06/16/2008N23241000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021952_claritin_toc.cfm 8/27/2009
AP04/6/2009SLR22230003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021952s003ltr.pdf 4/10/2009
AP012/9/2015SLR44731012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021952Orig1s012ltr.pdf 12/10/2015
AP012/9/2015SLR44746012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021952Orig1s012lbl.pdf 12/11/2015




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