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FDA Drug Application 205003 by SYMPLMED PHARMS LLC

Application Number205003
Application Type New Drug Application
Sponsor ApplicantSYMPLMED PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/21/2015N41663000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s000lbl.pdf 1/22/2015
AP01/21/2015N41670000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205003Orig1s000ltr.pdf 1/23/2015
AP01/21/2015N46877000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205003Orig1s000TOC.cfm 8/24/2016
AP01/21/2015N46878000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205003Orig1s000SumR.pdf 8/24/2016
AP08/25/2015SLR43716001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s001lbl.pdf 8/26/2015
AP08/25/2015SLR43735001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205003Orig1s001ltr.pdf 8/27/2015




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