Back to FDA Applications sponsored by ROXANE

FDA Drug Application 022402 by ROXANE

Application Number022402
Application Type New Drug Application
Sponsor ApplicantROXANE
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
AP07/16/2009N23009000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022402s000ltr.pdf 7/22/2009
AP07/16/2009N23067000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022402s000lbl.pdf 7/24/2009
AP07/16/2009N24354000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022402_codeine_sulfate_toc.cfm 12/30/2009
AP07/16/2009N24355000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022402s000_SumR.pdf 12/30/2009
AP04/17/2012SLR32473003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022402s003ltr.pdf 4/19/2012
AP04/17/2012SLR32484003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022402s003lbl.pdf 4/20/2012
AP06/17/2013SCM       
AP05/9/2013SLR36063006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022402Orig1s006ltr.pdf 5/14/2013
AP05/9/2013SLR36068006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022402s006lbl.pdf 5/14/2013




Back to FDA Applications sponsored by ROXANE