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FDA Drug Application 202245 by ROXANE

Application Number202245
Application Type New Drug Application
Sponsor ApplicantROXANE
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
AP06/30/2011N29412000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202245s000ltr.pdf 7/6/2011
AP06/30/2011N29429000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202245s000lbl.pdf 7/6/2011
AP06/30/2011N31742000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202245_codeine_toc.cfm 2/13/2012
AP06/30/2011N31743000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202245Orig1s000SumR.pdf 2/13/2012
AP04/17/2012SLR32474001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202245s001ltr.pdf 4/19/2012
AP04/17/2012SLR32485001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202245s001lbl.pdf 4/20/2012
AP04/17/2012SLR32486001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202245s001mg.pdf 4/20/2012
AP05/9/2013SLR36039002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202245Orig1s002ltr.pdf 5/13/2013
AP05/9/2013SLR36061002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202245s002lbl.pdf 5/14/2013
AP08/24/2016SCM       




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