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FDA Drug Application 021592 by NOVARTIS

Application Number021592
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/15/2006N15496000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021592lbl.pdf 12/26/2006
AP012/15/2006N15529000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021592s000ltr.pdf 12/28/2006
AP012/15/2006N15839000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088603.pdf 2/20/2007
AP012/15/2006N21265000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021592_foradil_certihaler_toc.cfm 11/25/2008
AP06/2/2010SLR25670003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021592s003lbl.pdf 6/2/2010
AP06/2/2010SLR25681003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020831s021,021592s003ltr.pdf 6/3/2010




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