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FDA Drug Application 022107 by NOVARTIS

Application Number022107
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
AP01/18/2008N21082000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022107_tekturna_toc.cfm 10/27/2008
AP01/18/2008N21083000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022107s000_SumR.pdf 10/27/2008
AP01/18/2008N18924000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022107lbl.pdf 1/23/2008
AP01/18/2008N18934000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022107s000ltr.pdf 1/23/2008
AP07/17/2008SLR20285001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022107s001ltr.pdf 7/23/2008
AP07/16/2009SE122992002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022107s002ltr.pdf 7/17/2009
AP07/16/2009SE123068002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022107s002lbl.pdf 7/24/2009
AP05/22/2010SLR25608005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022107s005ltr.pdf 5/24/2010
AP05/22/2010SLR25649005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s005lbl.pdf 5/28/2010
AP08/9/2010SLR26198007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022107s007lbl.pdf 8/9/2010
AP08/9/2010SLR26202007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022107s007ltr.pdf 8/11/2010
AP02/10/2011SLR27817009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s009lbl.pdf 2/11/2011
AP02/10/2011SLR27833009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s009ltr.pdf 2/14/2011
AP06/14/2011SLR29166013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s013ltr.pdf 6/16/2011
AP06/14/2011SLR29179013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s011s013lbl.pdf 6/16/2011
AP010/12/2011SLR30329014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022107s014ltr.pdf 10/14/2011
AP010/12/2011SLR30369014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022107s014lbl.pdf 10/20/2011
AP02/14/2012SLR31802016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s016ltr.pdf 2/17/2012
AP02/14/2012SLR31820016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/22107s016lbl.pdf 2/17/2012
AP01/26/2012SLR31586017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s017ltr.pdf 1/30/2012
AP01/26/2012SLR31613017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s017lbl.pdf 1/31/2012
AP02/2/2012SLR31791019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s019ltr.pdf 2/14/2012
AP04/16/2012SLR32452021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s021lbl.pdf 4/16/2012
AP04/16/2012SLR32467021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107s021ltr.pdf 4/18/2012
AP09/28/2012SLR33876022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022107s022lbl.pdf 10/1/2012
AP09/28/2012SLR33896022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022107Orig1s022ltr.pdf 10/2/2012
AP011/4/2013SLR37679023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022107s023lbl.pdf 11/4/2013
AP011/4/2013SLR37722023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022107Orig1s023ltr.pdf 11/7/2013
AP03/18/2014SLR38828024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022107s024lbl.pdf 3/19/2014
AP03/27/2015SLR42344025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s025ltr.pdf 4/1/2015
AP03/27/2015SLR42387025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s025lbl.pdf 4/2/2015
AP012/22/2015SLR44863026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s026ltr.pdf 12/23/2015
AP012/22/2015SLR44884026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022107s026lbl.pdf 12/28/2015
AP012/21/2015SCM       




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