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FDA Drug Application 050753 by NOVARTIS PHARMS

Application Number050753
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/22/1997N25615000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050753_tobi_toc.cfm 5/25/2010
AP09/11/1998SLR       
AP03/21/2002SLR3984002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50753s2ltr.pdf 3/21/2002
AP05/18/2000SCM       
AP09/5/2001SCP       
AP010/16/2008SLR21048009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050753s009ltr.pdf 10/22/2008
AP09/26/2013SLR37244011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050753s011lbl.pdf 9/27/2013
AP09/26/2013SLR37272011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050753Orig1s011ltr.pdf 10/1/2013
AP010/24/2013SCM       
AP04/25/2014SLR39158016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050753Orig1s016ltr.pdf 4/29/2014
AP04/25/2014SLR39176016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050753s016lbl.pdf 4/29/2014
AP04/14/2015SCM       
AP010/5/2015SLR44120018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050753Orig1s018ltr.pdf 10/6/2015
AP010/5/2015SLR44174018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050753s018lbl.pdf 10/8/2015
AP04/29/2016SCM       
AP09/28/2016SCM       




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