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FDA Drug Application 022235 by JAZZ

Application Number022235
Application Type New Drug Application
Sponsor ApplicantJAZZ
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/14/2008N19715000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022235lbl.pdf 4/23/2008
AP04/14/2008N19873000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022235s000ltr.pdf 5/22/2008
AP04/14/2008N23275000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022235_luvox_toc.cfm 9/3/2009
AP04/14/2008N23276000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/22235s000_SumR.pdf 9/3/2009
AP04/14/2008N28423000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249169.pdf 4/1/2011
AP04/14/2008N31751000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113425.htm 2/13/2012




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