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FDA Drug Application 022314 by NOVARTIS

Application Number022314
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/30/2009N22492000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022314lbl.pdf 5/11/2009
AP04/30/2009N22577000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022314s000ltr.pdf 5/14/2009
AP04/30/2009N23267000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022314s000TOC.cfm 9/2/2009
AP04/30/2009N23268000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022314s000_SumR.pdf 9/2/2009
AP06/3/2011SLR29110005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s005ltr.pdf 6/13/2011
AP06/3/2011SLR29273005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s005lbl.pdf 6/27/2011
AP012/7/2011SLR30942007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s007lbl.pdf 12/13/2011
AP012/7/2011SLR30947007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s007ltr.pdf 12/14/2011
AP02/16/2012SLR31826009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s009lbl.pdf 2/17/2012
AP02/16/2012SLR31841009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314s009ltr.pdf 2/21/2012
AP010/31/2011SLR30469011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s011ltr.pdf 11/2/2011
AP010/31/2011SLR30473011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s011lbl.pdf 10/31/2011
AP01/18/2012SLR31420012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990s017,022314s012ltr.pdf 1/20/2012
AP09/28/2012SLR33881013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s013lbl.pdf 10/1/2012
AP09/28/2012SLR33920013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314Orig1s013ltr.pdf 10/2/2012
AP011/28/2012SLR34499014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314Orig1s014ltr.pdf 11/29/2012
AP011/28/2012SLR34585014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s014lbl.pdf 12/10/2012
AP03/17/2014SLR38820015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022314Orig1s015,s016ltr.pdf 3/19/2014
AP03/17/2014SLR38838015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf 3/19/2014
AP03/17/2014SLR38839016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf 3/19/2014
AP03/17/2014SLR38819016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022314Orig1s015,s016ltr.pdf 3/19/2014
AP06/9/2014SCM39464017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s017lbl.pdf 6/10/2014
AP09/24/2014SLR40602019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022314Orig1s019ltr.pdf 9/25/2014
AP09/24/2014SLR40633019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s019lbl.pdf 9/26/2014
AP07/28/2015SLR43522020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022314Orig1s020ltr.pdf 7/30/2015
AP07/28/2015SLR43544020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022314s020lbl.pdf 7/30/2015
AP02/12/2016SCM       
AP12/12/2016SCM       




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