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FDA Drug Application 205098 by PROVENSIS

Application Number205098
Application Type New Drug Application
Sponsor ApplicantPROVENSIS
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
AP011/25/2013N37939000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205098s000lbl.pdf 11/26/2013
AP011/25/2013N37947000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205098Orig1s000ltr.pdf 11/27/2013
AP011/25/2013N40025000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205098Orig1s000TOC.cfm 7/28/2014
AP011/25/2013N40026000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205098Orig1s000SumR.pdf 7/28/2014
AP06/26/2014SCM39677001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205098Origs001ltr.pdf 6/27/2014
AP06/26/2014SCM39755001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205098s001lbl.pdf 7/3/2014
AP09/16/2014SCM       
AP012/11/2014SCM       
AP01/8/2015SLR41564005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205098Orig1s005ltr.pdf 1/9/2015
AP01/8/2015SLR41619005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205098s005lbledt.pdf 1/12/2015
AP01/20/2015SCM       
AP04/23/2015SCM       
AP06/2/2015SCM       
AP05/11/2015SCM       
AP08/6/2015SCM       
AP011/20/2015SCM       
AP03/4/2016SCM       
AP01/21/2016SCM       
AP04/18/2016SCM       
AP06/17/2016SCM       
AP06/23/2016SLR46417018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205098Orig1s018ltr.pdf 6/24/2016
AP06/23/2016SLR46423018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205098s018lbl.pdf 6/27/2016
AP09/8/2016SCM       
AP09/23/2016SCM       




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