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FDA Drug Application 022150 by SHIRE ORPHAN THERAP

Application Number022150
Application Type New Drug Application
Sponsor ApplicantSHIRE ORPHAN THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/25/2011N29903000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022150s000lbl.pdf 8/26/2011
AP08/25/2011N29910000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022150s000ltr.pdf 8/29/2011
AP08/25/2011N30191000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022150_firazyr_toc.cfm 10/3/2011
AP011/28/2012SCM       
AP01/28/2013SCM       
AP08/30/2013SLR36945004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022150Orig1s004ltr.pdf 9/4/2013
AP08/30/2013SLR37021004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022150s004lbl.pdf 9/9/2013
AP08/10/2015SLR43618006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022150Orig1s006ltr.pdf 8/11/2015
AP08/10/2015SLR43627006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s006lbl.pdf 8/11/2015
AP011/24/2015SLR44578007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022150Orig1s007ltr.pdf 11/25/2015
AP011/24/2015SLR44580007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s007lbl.pdf 11/25/2015
AP01/25/2016SCM       




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