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FDA Drug Application 018281 by NOVARTIS

Application Number018281
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
AP012/14/1981N34683000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246796.pdf 12/18/2012
AP02/11/1982SLR       
AP06/21/1983SCP       
AP01/10/1986SLR       
AP01/10/1986SLR       
AP02/3/1986SCP       
AP09/11/1986SCM       
AP07/31/1987SLR       
AP010/11/1995SE5       
AP08/1/1988SLR       
AP04/7/1989SCP       
AP07/21/1989SLR       
AP03/27/1990SCM       
AP03/29/1990SCM       
AP03/29/1990SCM       
AP03/26/1990SLR       
AP02/3/1995SCS       
AP011/23/1992SCF       
AP03/14/1991SCS       
AP010/6/1993SCS       
AP07/15/1998SLR       
AP07/15/1998SLR17111031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/018927_S031_TEGRETOL_AP.PDF 7/6/2007
AP07/15/1998SLR       
AP04/10/2000SLR       
AP07/15/1998SLR       
AP01/27/1999SCM       
AP04/23/1999SCP       
AP04/10/2000SLR       
AP04/11/2000SCM       
AP03/7/2001SLR3911039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF 3/7/2001
AP03/7/2001SLR3923039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF 3/7/2001
AP03/7/2001SLR17110039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018281_S039_TEGRETOL_AP.PDF 7/6/2007
AP05/18/2000SCM       
AP011/15/2001SCM       
AP01/28/2002SCS       
AP03/5/2002SCS       
AP08/16/2007SLR17640044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf 8/17/2007
AP08/16/2007SLR17649044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf 8/17/2007
AP08/28/2015SLR43774045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf 9/1/2015
AP08/28/2015SLR43789045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf 9/3/2015
AP012/11/2007SLR18644046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018281s046lbl.pdf 12/12/2007
AP012/11/2007SLR18845046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf 1/9/2008
AP09/16/2014SLR40510047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf 9/17/2014
AP09/16/2014SLR40525047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf 9/19/2014
AP04/23/2009SLR22373048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018281s048,020234s032ltr.pdf 5/1/2009
AP04/23/2009SLR22519048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf 5/12/2009
AP03/3/2011SLR28098049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf 3/7/2011
AP03/3/2011SLR28139049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf 3/7/2011
AP03/3/2011SLR28142049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf 3/7/2011
AP03/3/2011SLR28140050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf 3/7/2011
AP03/3/2011SLR28141050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf 3/7/2011
AP03/3/2011SLR28099050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf 3/7/2011
AP01/16/2014SLR38322051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf 1/17/2014
AP01/16/2014SLR38327051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf 1/17/2014
AP03/6/2013SLR35360053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf 3/8/2013
AP03/6/2013SLR35385053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf 3/8/2013
AP010/30/2011SLR       
AP012/11/2012SLR34631055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf 12/13/2012
AP012/11/2012SLR34652055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf 12/13/2012
AP011/8/2013SCM       




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