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FDA Drug Application 021124 by NOVARTIS

Application Number021124
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
AP03/17/2000N1273000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21124ltr.pdf 3/17/2000
AP03/17/2000N1274000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21124lbl.pdf 3/17/2000
AP03/17/2000N2772000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-124_TerbinafineLamisil.cfm 5/15/2002
AP05/9/2001SCS       
AP03/11/2002SCM       
AP04/8/2002SCM       
AP07/25/2002SCP       
AP07/25/2008SCP20340007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021124s007ltr.pdf 7/31/2008
AP06/15/2009SCP22768008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021124s008ltr.pdf 6/17/2009
AP02/12/2010SLR24825009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021124s009ltr.pdf 2/22/2010
AP03/20/2012SLR32183011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021124s011ltr.pdf 3/26/2012
AP011/13/2013SLR37822013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021124Orig1s013ltr.pdf 11/15/2013
AP011/13/2013SLR37848013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021124Orig1s013lbl.pdf 11/19/2013




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