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FDA Drug Application 022407 by THERAVANCE INC

Application Number022407
Application Type New Drug Application
Sponsor ApplicantTHERAVANCE INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/21/2013N36374000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=65 6/25/2013
AP06/21/2013N36381000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022407s000,022110s003lbl.pdf 6/25/2013
AP06/21/2013N36388000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022407Orig1s000,022110Orig1s003ltr.pdf 6/26/2013
AP06/21/2013N36399000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf 6/28/2013
AP06/21/2013N36437000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022407Orig1s000SumR.pdf 7/3/2013
AP06/21/2013N37368000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022407_vibativ_toc.cfm 10/7/2013




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