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FDA Drug Application 204300 by ECLAT PHARMS LLC

Application Number204300
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
AP06/27/2014N39695000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204300lbl.pdf 6/30/2014
AP06/27/2014N39696000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204300Orig1s000ltr.pdf 6/30/2014
AP06/27/2014N42823000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204300Orig1s000TOC.cfm 5/14/2015
AP06/27/2014N42824000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204300Orig1s000SumR.pdf 5/14/2015
AP01/2/2015SCM       
AP010/29/2015SCM       
AP05/28/2015SLR42949005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204300Orig1s005ltr.pdf 5/29/2015




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