Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019758
Company: HERITAGE LIFE
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 |
| CLOZARIL | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| CLOZARIL | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | AB | Yes | No |
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 |
|---|---|---|---|---|---|
| 05/19/2023 | SUPPL-103 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019758s103lbl.pdf | |
| 12/19/2022 | SUPPL-101 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019758s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019758Orig1s101ltr.pdf | |
| 11/10/2021 | SUPPL-99 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019758Orig1s099ltr.pdf |
| 07/29/2021 | SUPPL-98 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019758Orig1s098ltr.pdf |
| 02/18/2021 | SUPPL-96 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019758Orig1s096ltr.pdf |
| 04/14/2020 | SUPPL-95 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019758s095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019758Orig1s095ltr.pdf | |
| 01/16/2019 | SUPPL-90 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019758Orig1s090ltr.pdf |
| 02/11/2021 | SUPPL-88 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019758s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019758Orig1s088ltr.pdf | |
| 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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/019758Orig1s041.pdf |
| 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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/019758Orig1s036.pdf |
| 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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/019758Orig1s034.pdf |
| 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 |
|---|---|---|---|---|---|
| 05/19/2023 | SUPPL-103 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019758s103lbl.pdf | |
| 12/19/2022 | SUPPL-101 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019758s101lbl.pdf | |
| 02/11/2021 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019758s088lbl.pdf | |
| 04/14/2020 | SUPPL-95 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019758s095lbl.pdf | |
| 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 |
| CLOZAPINE | CLOZAPINE | 25MG | TABLET;ORAL | Prescription | No | AB | 074949 | IVAX SUB TEVA PHARMS |
| 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 |
| 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 | 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 |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 206433 | AUROBINDO PHARMA |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 074949 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 076809 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 075417 | MYLAN |
| CLOZAPINE | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | No | AB | 075713 | SUN PHARM INDS INC |
| CLOZARIL | CLOZAPINE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 019758 | HERITAGE LIFE |
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 206433 | AUROBINDO PHARMA |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 076809 | IVAX SUB TEVA PHARMS |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 075417 | MYLAN |
| CLOZAPINE | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 075713 | SUN PHARM INDS INC |
| CLOZARIL | CLOZAPINE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 019758 | HERITAGE LIFE |