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FDA Drug Application 205931 by AQUA PHARMS LLC

Application Number205931
Application Type New Drug Application
Sponsor ApplicantAQUA 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
AP07/25/2014N40007000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205931s000lbl.pdf 7/28/2014
AP07/25/2014N40015000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205931Orig1s000ltr.pdf 7/28/2014
AP07/25/2014N41304000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205931Orig1s000TOC.cfm 12/18/2014
AP08/15/2016SCM       
AP04/26/2016SLR45768002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205931s002lbl.pdf 4/27/2016
AP04/26/2016SLR45788002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205931Orig1s002ltr.pdf 4/28/2016




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