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FDA Drug Application 125293 by CREALTA PHARMS LLC

Application Number125293
Application Type Biologic License Application
Sponsor ApplicantCREALTA PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/14/2010N265020000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125293s000ltr.pdf 9/20/2010
AP09/14/2010N265060000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125293s0000lbl.pdf 9/20/2010
AP09/14/2010N265840000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM227568.pdf 9/30/2010
AP09/14/2010N269330000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293s0000TOC.cfm 11/12/2010
AP09/14/2010N279150000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293Orig1s000SumR.pdf 2/17/2011
AP010/19/2010S267720001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125293s001ltr.pdf 10/26/2010
AP04/16/2012SLR32451034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s034lbl.pdf 4/16/2012
AP04/16/2012SLR32470034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125293s034,s040ltr.pdf 4/18/2012
AP04/16/2012SLR32449040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s040lbl.pdf 4/16/2012
AP04/16/2012SLR32471040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125293s034,s040ltr.pdf 4/18/2012
AP010/10/2013SLR37423060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125293Orig1s060ltr.pdf 10/16/2013
AP07/17/2015SLR43415081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125293Orig1s081ltr.pdf 7/20/2015
AP07/17/2015SLR43443081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125293s081lbl.pdf 7/22/2015
AP07/30/2015SE843551083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125293Orig1s083ltr.pdf 7/31/2015
AP05/10/2016SLR45998085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s085lbl.pdf 5/11/2016
AP05/10/2016SLR46029085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s085ltr.pdf 5/16/2016
AP04/11/2016S45662086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s086ltr.pdf 4/12/2016
AP09/9/2016SLR47027089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s089lbl.pdf 9/12/2016
AP09/9/2016SLR47043089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s089ltr.pdf 9/15/2016




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