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FDA Drug Application 204399 by UPSHER-SMITH LABS

Application Number204399
Application Type New Drug Application
Sponsor ApplicantUPSHER-SMITH LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA08/16/2013TA36848000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204399Orig1s000TAltr.pdf 8/21/2013
TA08/16/2013TA39450000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204399Orig1s000ltr.pdf 6/5/2014
TA08/16/2013TA39496000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204399s000lbl.pdf 6/10/2014
TA08/16/2013TA39668000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=318 6/26/2014
TA08/16/2013TA42617000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204399Orig1s000TOC.cfm 4/22/2015
TA08/16/2013TA42619000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204399Orig1s000SumRedt.pdf 4/22/2015
AP16/4/2014N36848000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204399Orig1s000TAltr.pdf 8/21/2013
AP16/4/2014N39450000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204399Orig1s000ltr.pdf 6/5/2014
AP16/4/2014N39496000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204399s000lbl.pdf 6/10/2014
AP16/4/2014N39668000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=318 6/26/2014
AP16/4/2014N42617000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204399Orig1s000TOC.cfm 4/22/2015
AP16/4/2014N42619000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204399Orig1s000SumRedt.pdf 4/22/2015
AP05/11/2015SLR42791002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204399Orig1s002ltr.pdf 5/13/2015
AP05/11/2015SLR42814002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204399s002lbledt.pdf 5/13/2015
AP05/11/2015SLR42920002   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM448177.pdf 5/27/2015
AP05/12/2016SCM       
AP010/25/2016SLR47484004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204399Orig1s004ltr.pdf 10/27/2016




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