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FDA Drug Application 020234 by NOVARTIS

Application Number020234
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
AP03/25/1996N10754000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/020234ltr.pdf 12/8/2004
AP03/25/1996N10755000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/020234lbl.pdf 12/8/2004
AP03/25/1996N10756000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020234_complete_Approval_pkg.pdf 12/8/2004
AP03/25/1996N34685000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246796.pdf 12/18/2012
AP06/24/1996SCS       
AP07/15/1998SLR       
AP09/24/1996SCP       
AP07/26/1996SCS       
AP07/15/1998SLR       
AP07/15/1998SLR       
AP04/10/2000SLR       
AP07/15/1998SLR       
AP09/17/1998SCM       
AP01/4/1999SCM       
AP04/22/1999SCP       
AP06/29/1999SCE       
AP02/14/2000SCM       
AP04/10/2000SLR       
AP03/7/2000SCS       
AP04/11/2000SCM       
AP03/7/2001SLR17101017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020234_S017_TEGRETOL_AP.pdf 7/6/2007
AP03/7/2001SLR1552017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF 3/7/2001
AP03/7/2001SLR1553017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF 3/7/2001
AP01/11/2001SCS       
AP02/22/2001SCS       
AP011/15/2001SCM       
AP05/6/2002SCM       
AP01/28/2002SCS       
AP08/16/2007SLR17638025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf 8/17/2007
AP08/16/2007SLR17647025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf 8/17/2007
AP08/28/2015SLR43776026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf 9/1/2015
AP08/28/2015SLR43787026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf 9/3/2015
AP012/11/2007SLR18642028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020234s028lbl.pdf 12/12/2007
AP012/11/2007SLR18843028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf 1/9/2008
AP09/16/2014SLR40512030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf 9/17/2014
AP09/16/2014SLR40523030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf 9/19/2014
AP03/3/2011SLR28131031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf 3/7/2011
AP03/3/2011SLR28102031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf 3/7/2011
AP03/3/2011SLR28133031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf 3/7/2011
AP04/23/2009SLR22374032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018281s048,020234s032ltr.pdf 5/1/2009
AP04/23/2009SLR22521032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf 5/12/2009
AP03/3/2011SLR28134033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf 3/7/2011
AP03/3/2011SLR28103033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf 3/7/2011
AP03/3/2011SLR28132033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf 3/7/2011
AP01/16/2014SLR38320035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf 1/17/2014
AP01/16/2014SLR38325035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf 1/17/2014
AP03/6/2013SLR35362038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf 3/8/2013
AP03/6/2013SLR35383038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf 3/8/2013
AP010/30/2011SLR30556039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s106,018281s054,018927s047,020234s039ltr.pdf 11/10/2011
AP012/11/2012SLR34629040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf 12/13/2012
AP012/11/2012SLR34654040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf 12/13/2012
AP07/29/2013SCM       




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