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FDA Drug Application 016608 by NOVARTIS

Application Number016608
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/11/1968N10753000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016608_Tegretol.cfm 12/8/2004
AP03/11/1968N34682000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246796.pdf 12/18/2012
AP07/15/1974SLR       
AP08/29/1974SCS       
AP08/29/1974SCS       
AP08/29/1974SCS       
AP08/29/1974SCS       
AP08/29/1974SCS       
AP08/29/1974SCS       
AP08/29/1974SCS       
AP011/8/1974SCS       
AP08/20/1974SCS       
AP03/28/1975SDS       
AP011/15/1974SCS       
AP012/12/1974SCS       
AP03/31/1975SCS       
AP07/2/1975SCS       
AP011/8/1976SLR       
AP012/9/1975SCS       
AP012/12/1975SCS       
AP04/4/1977SCP       
AP04/4/1977SCS       
AP04/4/1977SCS       
AP08/9/1978SLR       
AP08/9/1978SLR       
AP011/22/1978SCS       
AP011/22/1978SCS       
AP04/9/1979SCM       
AP03/25/1980SLR       
AP02/1/1980SCM       
AP012/8/1981SLR       
AP02/9/1982SCP       
AP07/8/1982SCP       
AP07/31/1987SE5       
AP09/14/1983SCS       
AP07/31/1984SCM       
AP03/8/1985SCM       
AP05/6/1985SCS       
AP01/10/1986SLR       
AP06/2/1986SES       
AP01/10/1986SLR       
AP02/3/1986SLR       
AP07/31/1987SLR       
AP010/11/1995SE5       
AP08/8/1988SCS       
AP08/1/1988SLR       
AP04/7/1989SCP       
AP07/21/1989SLR       
AP03/27/1990SCM       
AP03/28/1990SCM       
AP03/28/1990SCM       
AP03/26/1990SLR       
AP06/1/1990SCS       
AP03/14/1991SCS       
AP010/6/1993SCS       
AP010/5/1995SCP       
AP07/15/1998SLR       
AP07/15/1998SLR       
AP03/6/1997SCE       
AP07/15/1998SLR       
AP04/10/2000SLR       
AP07/15/1998SLR       
AP04/21/1999SCP       
AP06/7/1999SCM       
AP04/10/2000SLR       
AP04/11/2000SCM       
AP03/7/2001SLR3912090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF 3/7/2001
AP03/7/2001SLR3913090   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF 3/7/2001
AP03/7/2001SLR16004090   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/016608_S090_TEGRETOL_AP.pdf 3/8/2007
AP05/18/2000SCM       
AP011/19/2001SCM       
AP011/15/2001SCM       
AP01/28/2002SCS       
AP08/16/2007SLR17641096   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf 8/17/2007
AP08/16/2007SLR17650096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf 8/17/2007
AP08/28/2015SLR43773097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf 9/1/2015
AP08/28/2015SLR43790097   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf 9/3/2015
AP012/11/2007SLR18641098   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf 12/12/2007
AP012/11/2007SLR18693098Clinical Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/016608s098,020712s029,021710_ClinRev.pdf 12/31/2007
AP012/11/2007SLR18846098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf 1/9/2008
AP09/16/2014SLR40509099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf 9/17/2014
AP09/16/2014SLR40526099   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf 9/19/2014
AP03/3/2011SLR28096100   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf 3/7/2011
AP03/3/2011SLR28143100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf 3/7/2011
AP03/3/2011SLR28145100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf 3/7/2011
AP04/23/2009SLR22371101   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016608s101,018927s043ltr.pdf 5/1/2009
AP04/23/2009SLR22518101   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf 5/12/2009
AP03/3/2011SLR28097102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf 3/7/2011
AP03/3/2011SLR28144102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf 3/7/2011
AP03/3/2011SLR28146102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf 3/7/2011
AP01/16/2014SLR38321103   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf 1/17/2014
AP01/16/2014SLR38328103   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf 1/17/2014
AP03/6/2013SLR35359105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf 3/8/2013
AP03/6/2013SLR35386105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf 3/8/2013
AP010/30/2011SLR30557106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s106,018281s054,018927s047,020234s039ltr.pdf 11/10/2011
AP012/11/2012SLR34632107   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf 12/13/2012
AP012/11/2012SLR34651107   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf 12/13/2012
AP011/8/2013SCM       
AP010/30/2015SCM       




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