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FDA Drug Application 204096 by ASTELLAS

Application Number204096
Application Type New Drug Application
Sponsor ApplicantASTELLAS
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
AP07/19/2013N36587000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096s000lbl.pdf 7/23/2013
AP07/19/2013N36595000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362199.pdf 7/24/2013
AP07/19/2013N36605000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204096Orig1s000ltr.pdf 7/26/2013
AP07/19/2013N40999000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204096Orig1s000SumR.pdf 11/17/2014
AP07/19/2013N41299000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204096Orig1s000OTOC.cfm 12/18/2014
AP02/10/2014SLR38507001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s001ltr.pdf 2/12/2014
AP02/28/2014SLR38647002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204096s002lbl.pdf 3/4/2014
AP02/28/2014SLR38658002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204096Orig1s002ltr.pdf 3/4/2014
AP012/16/2015SLR44813003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf 12/17/2015
AP012/16/2015SLR44827003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr.pdf 12/18/2015
AP012/16/2015SLR44814004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204096s003s004lbl.pdf 12/17/2015
AP012/16/2015SLR44826004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204096Orig1s003s004ltr.pdf 12/18/2015




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