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FDA Drug Application 018927 by NOVARTIS

Application Number018927
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/18/1987N34684000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246796.pdf 12/18/2012
AP07/28/1988SCM       
AP07/28/1988SCM       
AP08/1/1988SLR       
AP04/7/1989SCP       
AP07/21/1989SLR       
AP08/1/1989SCM       
AP03/26/1990SLR       
AP03/14/1991SCS       
AP010/6/1993SCS       
AP010/11/1995SE5       
AP08/9/1995SCM       
AP07/15/1998SLR       
AP07/15/1998SLR       
AP01/2/1997SCS       
AP07/15/1998SLR       
AP04/10/2000SLR       
AP07/15/1998SLR       
AP02/19/1999SCM       
AP012/29/1998SCS       
AP04/10/2000SLR       
AP03/8/2000SCM       
AP04/11/2000SCM       
AP03/7/2001SLR3802031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF 3/7/2001
AP03/7/2001SLR3805031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF 3/7/2001
AP011/15/2001SCM       
AP01/28/2002SCS       
AP012/11/2002SCM       
AP08/16/2007SLR17639035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf 8/17/2007
AP08/16/2007SLR17648035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf 8/17/2007
AP08/28/2015SLR43775038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf 9/1/2015
AP08/28/2015SLR43788038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf 9/3/2015
AP012/11/2007SLR18643039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018927s039lbl.pdf 12/12/2007
AP012/11/2007SLR18844039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf 1/9/2008
AP09/16/2014SLR40511040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf 9/17/2014
AP09/16/2014SLR40524040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf 9/19/2014
AP03/3/2011SLR28100041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf 3/7/2011
AP03/3/2011SLR28135041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf 3/7/2011
AP03/3/2011SLR28137041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf 3/7/2011
AP03/3/2011SLR28138042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf 3/7/2011
AP03/3/2011SLR28136042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf 3/7/2011
AP03/3/2011SLR28101042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf 3/7/2011
AP04/23/2009SLR22372043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016608s101,018927s043ltr.pdf 5/1/2009
AP04/23/2009SLR22520043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf 5/12/2009
AP01/16/2014SLR38323044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf 1/17/2014
AP01/16/2014SLR38326044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf 1/17/2014
AP03/6/2013SLR35361046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf 3/8/2013
AP03/6/2013SLR35384046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf 3/8/2013
AP010/30/2011SLR30558047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s106,018281s054,018927s047,020234s039ltr.pdf 11/10/2011
AP012/11/2012SLR34630048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf 12/13/2012
AP012/11/2012SLR34653048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf 12/13/2012
AP011/8/2013SCM       
AP06/17/2016SCM       
AP07/8/2016SCM       
AP08/19/2016SCM       
AP09/28/2016SCM       




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