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FDA Drug Application 205574 by ACCORD HLTHCARE

Application Number205574
Application Type Abbreviated New Drug Application
Sponsor ApplicantACCORD HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA012/4/2015TA44670000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205574Orig1s000TAltr.pdf 12/8/2015
TA012/4/2015TA46099000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205574Orig1s000ltr.pdf 5/20/2016
TA012/4/2015TA46169000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf 5/26/2016
AP15/19/2016N44670000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205574Orig1s000TAltr.pdf 12/8/2015
AP15/19/2016N46099000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205574Orig1s000ltr.pdf 5/20/2016
AP15/19/2016N46169000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf 5/26/2016




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