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FDA Drug Application 022129 by SHIONOGI INC

Application Number022129
Application Type New Drug Application
Sponsor ApplicantSHIONOGI INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/9/2009N22278000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022129lbl.pdf 4/16/2009
AP04/9/2009N22285000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022129s000ltr.pdf 4/16/2009
AP04/9/2009N22665000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022129s000TOC.cfm 6/1/2009
AP04/9/2009N22666000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022129s000_SumR.pdf 6/1/2009
AP06/22/2010SLR25802002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022129s002lbl.pdf 6/24/2010
AP06/22/2010SLR25821002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022129s002ltr.pdf 6/24/2010
AP07/12/2012SLR33205005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022129Orig1s005ltr.pdf 7/17/2012
AP07/12/2012SLR33317005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022129s005lbl.pdf 7/30/2012
AP03/24/2016SCM       
AP010/25/2016SCM       




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