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FDA Drug Application 204736 by FSC THERAP

Application Number204736
Application Type New Drug Application
Sponsor ApplicantFSC THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/26/2013N35554000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204736Orig1s000ltr.pdf 3/28/2013
AP03/26/2013N35596000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204736s000lbl.pdf 4/1/2013
AP03/26/2013N37980000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204736_aciphex_toc.cfm 12/6/2013
AP08/28/2013SCM       
AP04/4/2016SLR45587003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204736s003lbl.pdf 4/5/2016
AP04/4/2016SLR45592003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736Orig1s003ltr.pdf 4/6/2016
AP010/15/2014SLR40818004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf 10/16/2014
AP010/15/2014SLR40830004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204736Orig1s004,020973Orig1s034ltr.pdf 10/21/2014
AP012/19/2014SLR41384005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736Orig1s005ltr.pdf 12/24/2014
AP012/19/2014SLR41421005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf 12/29/2014
AP010/13/2015SCM       
AP010/24/2016SLR47439007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204736Orig1s007ltr.pdf 10/26/2016
AP010/24/2016SLR47513007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204736s007lbl.pdf 10/28/2016




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