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FDA Drug Application 201153 by GRACEWAY

Application Number201153
Application Type New Drug Application
Sponsor ApplicantGRACEWAY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/24/2011N28349000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201153s000,022483s001ltr.pdf 3/25/2011
AP03/24/2011N28389000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf 3/28/2011
AP03/24/2011N30200000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201153_zyclara_toc.cfm 10/3/2011
AP03/24/2011N30201000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201153Orig1s000SumR.pdf 10/3/2011




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