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FDA Drug Application 207174 by ACCORD HLTHCARE

Application Number207174
Application Type New Drug Application
Sponsor ApplicantACCORD HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/4/2016N45138000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207174Orig1s000ltr.pdf 2/9/2016
AP02/4/2016N45385000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207174s000lbl.pdf 3/4/2016
AP02/4/2016N47466000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207174Orig1s000TOC.cfm 10/26/2016




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