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FDA Drug Application 204308 by SILVERGATE PHARMS

Application Number204308
Application Type New Drug Application
Sponsor ApplicantSILVERGATE PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/13/2013N36784000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204308Orig1s000ltr.pdf 8/15/2013
AP08/13/2013N36805000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204308s000lbl.pdf 8/15/2013
AP08/13/2013N39678000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204308Orig1s000TOC.cfm 6/27/2014
AP08/13/2013N39679000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204308Orig1s000SumR.pdf 6/27/2014
AP02/3/2014SCM       
AP09/4/2014SE840462002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf 9/9/2014
AP09/4/2014SE840439002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204308Orig1s002,s003ltr.pdf 9/8/2014
AP09/4/2014SE840440003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204308Orig1s002,s003ltr.pdf 9/8/2014
AP09/4/2014SE840461003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf 9/9/2014
AP012/28/2015SCM       
AP01/29/2016SLR45055005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204308Orig1s005ltr.pdf 1/29/2016
AP01/29/2016SLR45080005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204308s005lbl.pdf 2/2/2016




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