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FDA Drug Application 205029 by BELCHER PHARMS LLC

Application Number205029
Application Type New Drug Application
Sponsor ApplicantBELCHER PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/29/2014N40076000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205029Orig1s000ltr.pdf 7/31/2014
AP07/29/2014N40240000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205029s000lbl.pdf 8/14/2014
AP07/29/2014N42330000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205029Orig1s000TOC.cfm 3/31/2015
AP09/23/2015SE844302001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205029Orig1s001ltr.pdf 10/26/2015
AP09/23/2015SE844306001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205029s001lbl.pdf 10/27/2015
AP02/11/2016SE845164002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s002ltr.pdf 2/12/2016
AP02/11/2016SE845202002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s002lbl.pdf 2/18/2016
AP012/3/2015SCM       
AP05/18/2016SLR46058004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s004ltr.pdf 5/19/2016
AP05/18/2016SLR46083004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s004lbl.pdf 5/20/2016




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