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FDA Drug Application 022110 by THERAVANCE BIOPHARMA

Application Number022110
Application Type New Drug Application
Sponsor ApplicantTHERAVANCE BIOPHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/11/2009N23318000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022110s000ltr.pdf 9/16/2009
AP09/11/2009N23405000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022110s000lbl.pdf 9/18/2009
AP09/11/2009N23454000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf 9/25/2009
AP09/11/2009N24155000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022110s000TOC.cfm 11/25/2009
AP09/11/2009N24156000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022110s000_SumR.pdf 11/25/2009
AP09/11/2009N29651000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=65 8/2/2011
AP07/27/2011SLR29619002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022110s002ltr_corrected.pdf 7/27/2011
AP06/21/2013S36380003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.pdf 6/25/2013
AP06/21/2013S36389003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022407Orig1s000,022110Orig1s003ltr.pdf 6/26/2013
AP02/1/2013SCM       
AP05/31/2013SCM       
AP02/7/2014SLR38480007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s007lbl.pdf 2/10/2014
AP012/12/2013SCM       
AP03/13/2014SCM38848009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s009lbl.pdf 3/19/2014
AP011/12/2014S40985010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s010ltr.pdf 11/14/2014
AP012/3/2014SLR41152011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022110Orig1s011ltr.pdf 12/4/2014
AP012/3/2014SLR41196011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022110s011lbl.pdf 12/10/2014
AP05/6/2016SE845887012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022110Orig1s012ltr.pdf 5/9/2016
AP05/6/2016SE845891012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022110s012lbl.pdf 5/9/2016
AP03/23/2016S45503013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022110Orig1s013ltr.pdf 3/25/2016
AP03/23/2016S45520013REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=65 3/29/2016




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