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FDA Drug Application 022545 by NOVARTIS

Application Number022545
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
AP08/26/2010N26291000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022545s000lbl.pdf 8/27/2010
AP08/26/2010N26312000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022545s000ltr.pdf 8/31/2010
AP08/26/2010N28945000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022545_tekamlo_toc.cfm 5/25/2011
AP08/26/2010N28946000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022545Origs000SumR.pdf 5/25/2011
AP03/30/2011SLR28420001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s001ltr.pdf 4/1/2011
AP03/30/2011SLR28432001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s001lbl.pdf 4/1/2011
AP010/12/2011SLR30328005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s005ltr.pdf 10/14/2011
AP010/12/2011SLR30370005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s005lbl.pdf 10/20/2011
AP01/25/2012SLR31618007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s007lbledt.pdf 1/31/2012
AP01/25/2012SLR31704007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s007ltr.pdf 2/7/2012
AP011/14/2011SLR30575008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022545s008lbl.pdf 11/14/2011
AP011/14/2011SLR30600008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022545s008ltr.pdf 11/16/2011
AP02/2/2012SLR31655010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s010ltr.pdf 2/6/2012
AP02/2/2012SLR31674010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s010lbl.pdf 2/6/2012
AP09/28/2012SLR33879011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf 10/1/2012
AP09/28/2012SLR33922011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013ltr.pdf 10/2/2012
AP04/16/2012SLR32454012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s012lbl.pdf 4/16/2012
AP04/16/2012SLR32468012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545s012ltr.pdf 4/18/2012
AP09/28/2012SLR33880013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022545s011s013.pdf 10/1/2012
AP09/28/2012SLR33923013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022545Orig1s011,s013ltr.pdf 10/2/2012
AP011/4/2013SLR37682014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022545s014lbl.pdf 11/4/2013
AP011/4/2013SLR37717014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022545Orig1s014ltr.pdf 11/6/2013
AP03/18/2014SLR38829015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022545s015lbl.pdf 3/19/2014
AP03/27/2015SLR42333016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s016ltr.pdf 4/1/2015
AP03/27/2015SLR42388016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s016lbl.pdf 4/2/2015
AP012/22/2015SLR44864017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022545Orig1s017ltr.pdf 12/23/2015
AP012/22/2015SLR44883017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022545s017lbl.pdf 12/28/2015




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