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 |
| 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 |