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FDA Drug Application 203505 by SHIONOGI INC

Application Number203505
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/26/2013N35271000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203505Orig1s000ltr.pdf 2/28/2013
AP02/26/2013N35299000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203505s000lbl.pdf 3/1/2013
AP02/26/2013N35558000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203505Orig1s000TOC.cfm 3/28/2013
AP08/13/2013SCM       
AP09/27/2013SCM       
AP01/8/2014SCM       
AP05/2/2014SCM       
AP02/25/2015SLR41942005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203505Orig1s005ltr.pdf 2/27/2015
AP02/25/2015SLR41963005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203505s005lbl.pdf 3/2/2015
AP04/23/2015SCM       
AP04/20/2015SCM       
AP08/24/2015SCM       
AP08/24/2015SCM       
AP08/24/2015SCM       




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