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FDA Drug Application 204078 by ECLAT PHARMS LLC

Application Number204078
Application Type New Drug Application
Sponsor ApplicantECLAT PHARMS LLC
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
AP05/31/2013N36198000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204078Orig1s000ltr.pdf 6/4/2013
AP05/31/2013N36211000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204078s000lbl.pdf 6/4/2013
AP05/31/2013N39362000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204078Orig1s000TOC.cfm 5/27/2014
AP05/31/2013N39365000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204078Orig1s000SumR.pdf 5/27/2014
AP06/18/2014SCM       
AP09/22/2014SCM       
AP012/11/2014SLR41236004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204078Orig1s004ltr.pdf 12/12/2014
AP012/11/2014SLR41274004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204078s004lbl.pdf 12/16/2014
AP09/30/2014SCM       
AP012/2/2014SCM       
AP010/20/2015SLR44232007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204078Orig1s007ltr.pdf 10/21/2015
AP010/20/2015SLR44256007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204078s007lbl.pdf 10/22/2015




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