Treats schizophrenia. NDA 19758, held by Heritage Life. Clozapine.
As of Nov 13, 2026, NDA 19758 (Clozaril), held by Heritage Life, was first approved by FDA on Sep 26, 1989, with 83 approved supplements and 0 published complete response letters.
CLOZARIL is an atypical antipsychotic indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 2002 | Supplement 47Efficacy (new indication or use) · Priority review | Approved | |
| Sep 26, 1989 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clozaril25MG · tablet;oral | Clozapine | RxReference drug |
| Clozaril100MG · tablet;oral | Clozapine | RxReference drug |
| Clozaril50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clozapine | DiscontinuedReference drug |
| Clozaril200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clozapine | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 2025 | Supplement 107REMS | Approved | |
| Jan 22, 2025 | Supplement 106Labeling · Standard review | Approved | |
| Sep 12, 2024 | Supplement 104Labeling · Standard review | Approved | |
| May 19, 2023 | Supplement 103Labeling · Standard review | Approved | |
| Dec 19, 2022 | Supplement 101Labeling · Standard review | Approved | |
| Nov 10, 2021 | Supplement 99REMS | Approved | |
| Jul 29, 2021 | Supplement 98REMS | Approved | |
| Feb 18, 2021 | Supplement 96REMS | Approved | |
| Feb 11, 2021 | Supplement 88Labeling · Standard review | Approved | |
| Apr 14, 2020 | Supplement 95Labeling | Approved | |
| Jan 16, 2019 | Supplement 90REMS | Approved | |
| Feb 23, 2017 | Supplement 84Labeling | Approved | |
| Jan 26, 2017 | Supplement 81Labeling · Standard review | Approved | |
| Dec 20, 2016 | Supplement 80Labeling · Standard review | Approved | |
| May 6, 2016 | Supplement 79Manufacturing · Priority review | Approved | None posted |
| Nov 10, 2015 | Supplement 76Manufacturing · Priority review | Approved | None posted |
| Oct 8, 2015 | Supplement 78Labeling · Standard review | Approved | |
| Sep 18, 2015 | Supplement 74Labeling · Standard review | Approved | |
| Sep 15, 2015 | Supplement 61REMS | Approved | |
| Sep 15, 2015 | Supplement 77Labeling · Standard review | Approved | |
| Dec 19, 2014 | Supplement 73Labeling · Standard review | Approved | |
| Sep 30, 2014 | Supplement 64Manufacturing · Priority review | Approved | None posted |
| Sep 29, 2014 | Supplement 72Labeling · Standard review | Approved | |
| Jul 19, 2013 | Supplement 69Labeling · Standard review | Approved | |
| Jul 19, 2013 | Supplement 71Labeling · Standard review | Approved | |
| Mar 22, 2013 | Supplement 67Labeling · Standard review | Approved | |
| Mar 22, 2013 | Supplement 68Labeling · Standard review | Approved | |
| Mar 22, 2013 | Supplement 70Labeling · Standard review | Approved | |
| Oct 19, 2011 | Supplement 63Labeling | Approved | |
| Dec 1, 2010 | Supplement 65Labeling | Approved | |
| Jan 14, 2010 | Supplement 62Labeling · Standard review | Approved | |
| Nov 6, 2008 | Supplement 53Labeling · Standard review | Approved | |
| Aug 14, 2008 | Supplement 59Labeling · Standard review | Approved | |
| Jun 26, 2008 | Supplement 58Labeling · Standard review | Approved | |
| Dec 5, 2005 | Supplement 57Labeling · Standard review | Approved | |
| Jun 29, 2005 | Supplement 56Labeling · Standard review | Approved | |
| May 12, 2005 | Supplement 54Labeling · Standard review | Approved | |
| Dec 23, 2003 | Supplement 51Labeling · Standard review | Approved | |
| Dec 18, 2002 | Supplement 47Efficacy (new indication or use) · Priority review | Approved | |
| Jul 5, 2002 | Supplement 48Labeling · Standard review | Approved | |
| Jan 14, 2002 | Supplement 45Labeling · Standard review | Approved | |
| Dec 14, 2001 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Aug 29, 2001 | Supplement 44Labeling · Standard review | Approved | |
| May 18, 2001 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| May 17, 2000 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Mar 17, 2000 | Supplement 41Labeling · Standard review | Approved | |
| Nov 1, 1999 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Oct 15, 1999 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Aug 9, 1999 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Apr 15, 1999 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Aug 19, 1998 | Supplement 36Labeling · Standard review | Approved | |
| Mar 3, 1998 | Supplement 34Labeling · Standard review | Approved | |
| Sep 19, 1997 | Supplement 35Labeling · Standard review | Approved | |
| Jun 27, 1997 | Supplement 32Labeling · Standard review | Approved | None posted |
| Apr 25, 1997 | Supplement 23Labeling · Standard review | Approved | None posted |
| Apr 25, 1997 | Supplement 25Labeling · Standard review | Approved | None posted |
| Apr 25, 1997 | Supplement 27Labeling · Standard review | Approved | None posted |
| Apr 25, 1997 | Supplement 33Labeling · Standard review | Approved | None posted |
| Jan 13, 1997 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| May 7, 1996 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Nov 22, 1995 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Oct 17, 1995 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Aug 31, 1995 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Aug 31, 1995 | Supplement 16Labeling · Standard review | Approved | None posted |
| May 10, 1995 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Mar 7, 1995 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Aug 30, 1994 | Supplement 22Labeling · Standard review | Approved | None posted |
| Aug 5, 1994 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Aug 1, 1994 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jul 15, 1994 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| May 20, 1994 | Supplement 21Labeling · Standard review | Approved | None posted |
| Mar 25, 1994 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Mar 25, 1994 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Mar 25, 1994 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Oct 27, 1992 | Supplement 10Labeling | Approved | None posted |
| Aug 20, 1992 | Supplement 14Labeling | Approved | None posted |
| Aug 10, 1992 | Supplement 11Labeling | Approved | None posted |
| Sep 4, 1991 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jun 12, 1991 | Supplement 2Labeling | Approved | None posted |
| Jun 12, 1991 | Supplement 5Labeling | Approved | None posted |
| Jun 12, 1991 | Supplement 6Labeling | Approved | None posted |
| Jun 12, 1991 | Supplement 8Labeling | Approved | None posted |
| Feb 5, 1990 | Supplement 1Labeling | Approved | None posted |
| Sep 26, 1989 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
