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FDA Drug Application 022195 by ROXANE

Application Number022195
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
AP03/17/2008N19485000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022195s000, 022207s000ltr.pdf 3/19/2008
AP03/17/2008N19515000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf 3/24/2008
AP03/17/2008N22149000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195_022207_morphine_toc.cfm 4/1/2009
AP03/17/2008N22150000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195s000_022207s000_SumR.pdf 4/1/2009
AP03/17/2008N34115000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM199333.pdf 10/17/2012
AP01/25/2010SE224669002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022195s002lbl.pdf 1/29/2010
AP01/25/2010SE224670002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022195s002MedGuide.pdf 1/29/2010
AP01/25/2010SE224681002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022195s002ltr.pdf 1/29/2010
AP06/10/2011SLR       
AP010/18/2011SLR30355005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022195s005ltr.pdf 10/20/2011
AP01/23/2012SLR31495006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022195s006lbl.pdf 1/23/2012
AP01/23/2012SLR31514006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022195s006ltr.pdf 1/25/2012
AP04/21/2015SCM42627007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022195Orig1s007ltr.pdf 4/22/2015
AP04/21/2015SCM42641007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022195s007lbl.pdf 4/23/2015
AP04/18/2014SCM       
AP01/9/2014SLR38261009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022195Orig1s009ltr.pdf 1/14/2014




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