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FDA Drug Application 021560 by NOVARTIS

Application Number021560
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/20/2010N25399000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021560s000ltr.pdf 4/29/2010
AP04/20/2010N25400000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM209840.pdf 4/30/2010
AP04/20/2010N25434000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021560s000lbl.pdf 5/3/2010
AP04/20/2010N25744000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000_zortress_toc.cfm 6/16/2010
AP04/20/2010N25745000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000sumr.pdf 6/16/2010
AP011/21/2011SLR30776004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021560s004ltr.pdf 11/28/2011
AP02/15/2013SE135191006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021560s006lbl.pdf 2/20/2013
AP02/15/2013SE135197006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021560Orig1s006ltr.pdf 2/20/2013
AP04/26/2012SLR32550007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560Orig1s007ltr.pdf 4/27/2012
AP04/26/2012SLR32576007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s007lbl.pdf 5/1/2012
AP010/2/2012SLR33959008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560Orig1s008ltr.pdf 10/4/2012
AP010/2/2012SLR33969008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s008lbl.pdf 10/4/2012
AP010/2/2012SLR33970008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s008mg.pdf 10/4/2012
AP05/2/2012SLR32617009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560s009ltr.pdf 5/4/2012
AP03/26/2013SCM       
AP01/27/2015SLR41707011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021560Orig1s011ltr.pdf 1/28/2015
AP01/27/2015SLR41741011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s011lbl.pdf 1/30/2015
AP012/5/2013SCM       
AP011/14/2013SCM       
AP06/24/2015SCM       
AP03/1/2016SCM       
AP011/5/2015SLR44424018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021560Orig1s018ltr.pdf 11/9/2015
AP011/5/2015SLR44441018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s018lbl.pdf 11/12/2015
AP010/12/2016SE847361019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021560Orig1s019ltr.pdf 10/14/2016
AP010/12/2016SE847379019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021560s019lbl.pdf 10/17/2016




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