Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019758
Company: HERITAGE LIFE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOZARIL CLOZAPINE 25MG TABLET;ORAL Prescription AB Yes No
CLOZARIL CLOZAPINE 100MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/26/1989 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-84 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019758Orig1s084ltr.pdf
01/26/2017 SUPPL-81 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019758Orig1s081ltr.pdf
12/20/2016 SUPPL-80 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019758s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019758Orig1s80ltr.pdf
05/06/2016 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

10/08/2015 SUPPL-78 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s078ltr.pdf
09/15/2015 SUPPL-77 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s061,s077ltr.pdf
11/10/2015 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

09/18/2015 SUPPL-74 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s074ltr.pdf
12/19/2014 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019758Orig1s073ltr.pdf
09/29/2014 SUPPL-72 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019758Orig1s072ltr.pdf
07/19/2013 SUPPL-71 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf
03/22/2013 SUPPL-70 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s070ltr.pdf
07/19/2013 SUPPL-69 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s069ltr.pdf
03/22/2013 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s070ltr.pdf
03/22/2013 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019758Orig1s067,s068,s070ltr.pdf
12/01/2010 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019758s065ltr.pdf
09/30/2014 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

10/19/2011 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019758s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019758s063ltr.pdf
01/14/2010 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019758s062ltr.pdf
09/15/2015 SUPPL-61 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019758Orig1s061,s077ltr.pdf
08/14/2008 SUPPL-59 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s059ltr.pdf
06/26/2008 SUPPL-58 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s058ltr.pdf
12/05/2005 SUPPL-57 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s057ltr.pdf
06/29/2005 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s056ltr.pdf
05/12/2005 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019758s054ltr.pdf
11/06/2008 SUPPL-53 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019758s053ltr.pdf
12/23/2003 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19758slr051ltr.pdf
07/05/2002 SUPPL-48 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758s048ltr.pdf
12/18/2002 SUPPL-47 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758se1-047_Clozaril_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758se1-047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019758Orig1s047.pdf
12/14/2001 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

01/14/2002 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758s45lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19758s45ltr.pdf
08/29/2001 SUPPL-44 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19758s44lbl.pdf
05/18/2001 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/2000 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/17/2000 SUPPL-41 Labeling

Label is not available on this site.

10/15/1999 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1999 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/15/1999 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/09/1999 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/19/1998 SUPPL-36 Labeling

Label is not available on this site.

09/19/1997 SUPPL-35 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019758_S035_CLOZARIL_TABS.pdf
03/03/1998 SUPPL-34 Labeling

Label is not available on this site.

04/25/1997 SUPPL-33 Labeling

Label is not available on this site.

06/27/1997 SUPPL-32 Labeling

Label is not available on this site.

01/13/1997 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1996 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/25/1997 SUPPL-27 Labeling

Label is not available on this site.

10/17/1995 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1997 SUPPL-25 Labeling

Label is not available on this site.

05/10/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/25/1997 SUPPL-23 Labeling

Label is not available on this site.

08/30/1994 SUPPL-22 Labeling

Label is not available on this site.

05/20/1994 SUPPL-21 Labeling

Label is not available on this site.

07/15/1994 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1995 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1994 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1995 SUPPL-16 Labeling

Label is not available on this site.

08/31/1995 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/20/1992 SUPPL-14 Labeling

Label is not available on this site.

08/01/1994 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/25/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1992 SUPPL-11 Labeling

Label is not available on this site.

10/27/1992 SUPPL-10 Labeling

Label is not available on this site.

09/04/1991 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1991 SUPPL-8 Labeling

Label is not available on this site.

06/12/1991 SUPPL-6 Labeling

Label is not available on this site.

06/12/1991 SUPPL-5 Labeling

Label is not available on this site.

03/25/1994 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/25/1994 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1991 SUPPL-2 Labeling

Label is not available on this site.

02/05/1990 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2017 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s084lbl.pdf
01/26/2017 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s081lbl.pdf
12/20/2016 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019758s080lbl.pdf
10/08/2015 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s078lbl.pdf
09/18/2015 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s074lbl.pdf
09/15/2015 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf
09/15/2015 SUPPL-61 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf
12/19/2014 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s073lbl.pdf
09/29/2014 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s072lbl.pdf
07/19/2013 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf
07/19/2013 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf
07/19/2013 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf
03/22/2013 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf
03/22/2013 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf
03/22/2013 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf
10/19/2011 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019758s063lbl.pdf
12/01/2010 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s065lbl.pdf
01/14/2010 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s062lbl.pdf
06/29/2005 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s056lbl.pdf
05/12/2005 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s054lbl.pdf
12/18/2002 SUPPL-47 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758se1-047_Clozaril_lbl.pdf
01/14/2002 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758s45lbl.pdf
08/29/2001 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19758s44lbl.pdf

CLOZARIL

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 202873 ACCORD HLTHCARE
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 206433 AUROBINDO PHARMA LTD
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 074949 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 203807 MAYNE PHARMA
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 075417 MYLAN
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 075713 SUN PHARM INDS INC
CLOZARIL CLOZAPINE 25MG TABLET;ORAL Prescription Yes AB 019758 HERITAGE LIFE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 202873 ACCORD HLTHCARE
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 206433 AUROBINDO PHARMA LTD
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 074949 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 076809 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 203807 MAYNE PHARMA
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 075417 MYLAN
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 075713 SUN PHARM INDS INC
CLOZARIL CLOZAPINE 100MG TABLET;ORAL Prescription Yes AB 019758 HERITAGE LIFE

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