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FDA Drug Application 022207 by ROXANE

Application Number022207
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
AP03/17/2008N19486000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022195s000, 022207s000ltr.pdf 3/19/2008
AP03/17/2008N19516000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf 3/24/2008
AP03/17/2008N22151000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195_022207_morphine_toc.cfm 4/1/2009
AP03/17/2008N22152000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022195s000_022207s000_SumR.pdf 4/1/2009
AP04/15/2010SLR25323002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022207s002ltr.pdf 4/21/2010
AP01/23/2012SLR31494004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022207s004lbl.pdf 1/23/2012
AP01/23/2012SLR31515004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022207s004ltr.pdf 1/25/2012




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