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FDA Drug Application 021958 by NOVARTIS

Application Number021958
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/24/2006N14537000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021958lbl.pdf 7/27/2006
AP07/24/2006N14547000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021958s000LTR.pdf 7/27/2006
AP07/24/2006N20166000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021958TOC.cfm 7/8/2008
AP01/6/2010SLR24523002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021958s002ltr.pdf 1/15/2010
AP03/20/2012SLR32182003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021958s003ltr.pdf 3/26/2012
AP01/24/2013SCM       




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