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FDA Drug Application 200045 by NOVARTIS

Application Number200045
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
AP012/21/2010N27380000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200045s000lbl.pdf 12/26/2010
AP012/21/2010N27410000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200045s000ltr.pdf 12/28/2010
AP012/21/2010N29780000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045s000_amturnide_toc.cfm 8/15/2011
AP012/21/2010N29781000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200045Orig1s000SumR.pdf 8/15/2011
AP010/12/2011SLR30327003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s003,s004ltr.pdf 10/14/2011
AP010/12/2011SLR30371003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf 10/20/2011
AP010/12/2011SLR30372004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s003s004lbl.pdf 10/20/2011
AP010/12/2011SLR30326004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s003,s004ltr.pdf 10/14/2011
AP02/14/2012SLR31804006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s006ltr.pdf 2/17/2012
AP02/14/2012SLR31819006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s006lbl.pdf 2/17/2012
AP01/25/2012SLR31577007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s007ltr.pdf 1/30/2012
AP01/25/2012SLR31619007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s007lbl.pdf 1/31/2012
AP011/2/2011SLR30495009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200045s009lbl.pdf 11/4/2011
AP011/2/2011SLR30527009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200045s009ltr.pdf 11/7/2011
AP02/2/2012SLR31659010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045s010ltr.pdf 2/6/2012
AP02/2/2012SLR31673010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s010lbl.pdf 2/6/2012
AP09/28/2012SLR33929011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s011,s013ltr.pdf 10/2/2012
AP09/28/2012SLR33877011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf 10/1/2012
AP04/16/2012SLR32455012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s012lbl.pdf 4/16/2012
AP04/16/2012SLR32469012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s012ltr_rev1rev2nh_Redacted.pdf 4/18/2012
AP09/28/2012SLR33878013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200045s011s013lbl.pdf 10/1/2012
AP09/28/2012SLR33930013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200045Orig1s011,s013ltr.pdf 10/2/2012
AP011/4/2013SLR37680014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200045s014lbl.pdf 11/4/2013
AP011/4/2013SLR37716014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200045Orig1s014ltr.pdf 11/6/2013
AP03/18/2014SLR38830015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200045s015lbl.pdf 3/19/2014
AP03/27/2015SLR42332016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200045Orig1s016ltr.pdf 4/1/2015
AP03/27/2015SLR42389016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s016lbl.pdf 4/2/2015
AP012/22/2015SLR44866017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200045Orig1s017ltr.pdf 12/23/2015
AP012/22/2015SLR44881017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200045s017lbl.pdf 12/28/2015




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