Back to FDA Applications sponsored by ORTHO MCNEIL PHARM

FDA Drug Application 021690 by ORTHO MCNEIL PHARM

Application Number021690
Application Type New Drug Application
Sponsor ApplicantORTHO MCNEIL PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/13/2005N11600000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690lbl.pdf 5/13/2005
AP05/13/2005N11601000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021690ppi.pdf 5/13/2005
AP05/13/2005N11632000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021690ltr.pdf 5/17/2005
AP05/13/2005N17688000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021690s000TOC.cfm 8/22/2007
AP05/1/2015SLR42718001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019653Orig1s056,019697Orig1s052,021690Orig1s001ltr.pdf 5/4/2015
AP05/1/2015SLR42722001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019653s056,019697s052,021690s001lbl.pdf 5/4/2015




Back to FDA Applications sponsored by ORTHO MCNEIL PHARM