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FDA Drug Application 206317 by ROCKWELL MEDICAL INC

Application Number206317
Application Type New Drug Application
Sponsor ApplicantROCKWELL MEDICAL INC
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
AP01/23/2015N41686000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206317Orig1s000ltr.pdf 1/26/2015
AP01/23/2015N41725000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206317s000lbl.pdf 1/29/2015
AP01/23/2015N45313000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206317Orig1s000TOC.cfm 3/2/2016
AP01/23/2015N45314000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206317Orig1s000SumR.pdf 3/2/2016
AP09/10/2015SCM       
AP05/16/2016SCM       
AP011/12/2015SCM       
AP08/19/2016SCM       
AP08/15/2016SCM       
AP07/28/2016SCM       




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