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FDA Drug Application 019758 by HERITAGE LIFE

Application Number019758
Application Type New Drug Application
Sponsor ApplicantHERITAGE LIFE
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
AP09/26/1989N31188000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP09/26/1989N43876000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351 9/16/2015
AP02/5/1990SLR       
AP06/12/1991SLR       
AP03/25/1994SCP       
AP03/25/1994SCP       
AP06/12/1991SLR       
AP06/12/1991SLR       
AP06/12/1991SLR       
AP09/4/1991SCS       
AP010/27/1992SLR       
AP08/10/1992SLR       
AP03/25/1994SCS       
AP08/1/1994SCP       
AP08/20/1992SLR       
AP08/31/1995SCF       
AP08/31/1995SLR       
AP08/5/1994SCS       
AP03/7/1995SCS       
AP07/15/1994SCS       
AP05/20/1994SLR       
AP08/30/1994SLR       
AP04/25/1997SLR       
AP05/10/1995SCM       
AP04/25/1997SLR       
AP010/17/1995SCS       
AP04/25/1997SLR       
AP011/22/1995SCM       
AP05/7/1996SCS       
AP01/13/1997SCS       
AP06/27/1997SLR       
AP04/25/1997SLR       
AP03/3/1998SLR       
AP09/19/1997SLR19211035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019758_S035_CLOZARIL_TABS.pdf 2/19/2008
AP08/19/1998SLR       
AP08/9/1999SCP       
AP04/15/1999SCP       
AP011/1/1999SCM       
AP010/15/1999SCS       
AP03/17/2000SLR       
AP05/17/2000SCM       
AP05/18/2001SCS       
AP08/29/2001SLR5922044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19758s44lbl.pdf 6/16/2003
AP01/14/2002SLR2527045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758s45ltr.pdf 1/14/2002
AP01/14/2002SLR2528045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758s45lbl.pdf 1/14/2002
AP012/14/2001SCM       
AP012/18/2002SE14876047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758se1-047_Clozaril_lbl.pdf 4/4/2003
AP012/18/2002SE18845047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758se1-047ltr.pdf 6/1/2004
AP012/18/2002SE132107047   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019758Orig1s047.pdf 3/14/2012
AP07/5/2002SLR2526048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758s048ltr.pdf 7/5/2002
AP012/23/2003SLR7415051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19758slr051ltr.pdf 12/24/2003
AP011/6/2008SLR21138053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s053ltr.pdf 11/6/2008
AP05/12/2005SLR11605054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s054ltr.pdf 5/17/2005
AP05/12/2005SLR11634054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s054lbl.pdf 5/17/2005
AP06/29/2005SLR11909056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s056ltr.pdf 6/29/2005
AP06/29/2005SLR11926056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s056lbl.pdf 6/29/2005
AP012/5/2005SLR13244057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s057ltr.pdf 12/13/2005
AP06/26/2008SLR20139058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s058ltr.pdf 7/1/2008
AP08/14/2008SLR20623059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s059ltr.pdf 8/19/2008
AP09/15/2015SE843890061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s061,s077ltr.pdf 9/16/2015
AP09/15/2015SE843891061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf 9/16/2015
AP01/14/2010SLR24544062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s062lbl.pdf 1/20/2010
AP01/14/2010SLR24641062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019758s062ltr.pdf 1/26/2010
AP010/19/2011SLR30396063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019758s063ltr.pdf 10/24/2011
AP010/19/2011SLR30424063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019758s063lbl.pdf 10/25/2011
AP09/30/2014SCM       
AP012/1/2010SLR27172065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s065lbl.pdf 12/4/2010
AP012/1/2010SLR27199065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019758s065ltr.pdf 12/6/2010
AP03/22/2013SLR35504067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s070ltr.pdf 3/25/2013
AP03/22/2013SLR35514067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf 3/26/2013
AP03/22/2013SLR35505068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s070ltr.pdf 3/25/2013
AP03/22/2013SLR35515068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf 3/26/2013
AP07/19/2013SLR36581069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s069ltr.pdf 7/22/2013
AP07/19/2013SLR36589069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf 7/23/2013
AP03/22/2013SLR35503070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s070ltr.pdf 3/25/2013
AP03/22/2013SLR35516070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf 3/26/2013
AP07/19/2013SLR36590071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf 7/23/2013
AP09/29/2014SLR40674072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s072lbl.pdf 9/30/2014
AP09/29/2014SLR40681072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019758Orig1s072ltr.pdf 10/1/2014
AP012/19/2014SLR41370073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019758Orig1s073ltr.pdf 12/23/2014
AP012/19/2014SLR41586073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s073lbl.pdf 1/9/2015
AP09/18/2015SLR43941074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s074ltr.pdf 9/22/2015
AP09/18/2015SLR43959074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s074lbl.pdf 9/23/2015
AP011/10/2015SCM       
AP09/15/2015SLR43889077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s061,s077ltr.pdf 9/16/2015
AP09/15/2015SLR43892077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf 9/16/2015
AP010/8/2015SLR44187078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s078ltr.pdf 10/13/2015
AP010/8/2015SLR44249078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s078lbl.pdf 10/22/2015
AP05/6/2016SCM       




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