Treats schizophrenia. NDA 18701, held by Janssen Pharms. Haloperidol Decanoate.
As of Nov 13, 2026, NDA 18701 (Haldol), held by Janssen Pharms, was first approved by FDA on Jan 14, 1986, with 57 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Haloperidol decanoate 50 and Haloperidol decanoate 100 are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 1986 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| HaldolEQ 50MG BASE/ML · injectable;injection | Haloperidol Decanoate | DiscontinuedReference drug |
| HaldolEQ 100MG BASE/ML · injectable;injection | Haloperidol Decanoate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 30, 2025 | Supplement 77Labeling · Standard review | Approved | |
| Jan 22, 2025 | Supplement 78Labeling · Standard review | Approved | |
| Nov 17, 2020 | Supplement 76Labeling · Standard review | Approved | |
| Nov 17, 2020 | Supplement 71Labeling · Standard review | Approved | |
| Mar 8, 2019 | Supplement 73Labeling · Standard review | Approved | |
| Dec 5, 2017 | Supplement 70Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 74Labeling | Approved | |
| May 18, 2016 | Supplement 72Labeling · Standard review | Approved | |
| Dec 19, 2013 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Jun 5, 2013 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| May 24, 2013 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| May 6, 2013 | Supplement 65Labeling · Standard review | Approved | |
| Aug 12, 2011 | Supplement 54Labeling · Standard review | Approved | |
| Mar 1, 2011 | Supplement 63Labeling · Standard review | Approved | |
| Dec 1, 2010 | Supplement 62Labeling | Approved | |
| Jul 19, 2009 | Supplement 59Labeling | Approved | |
| Aug 14, 2008 | Supplement 57Labeling · Standard review | Approved | |
| May 13, 2008 | Supplement 56Labeling · Standard review | Approved | |
| Sep 19, 2007 | Supplement 55Labeling · Standard review | Approved | |
| May 4, 2007 | Supplement 53Labeling · Standard review | Approved | |
| Apr 17, 2002 | Supplement 46Labeling · Standard review | Approved | |
| May 2, 2000 | Supplement 43Labeling · Standard review | Approved | None posted |
| Apr 13, 2000 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jun 23, 1998 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Sep 11, 1997 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1997 | Supplement 29Labeling | Approved | None posted |
| Jan 31, 1997 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| May 10, 1996 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| May 22, 1995 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1994 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1994 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Apr 27, 1993 | Supplement 36Labeling · Standard review | Approved | None posted |
| Apr 21, 1993 | Supplement 34Labeling | Approved | None posted |
| Dec 21, 1990 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1989 | Supplement 32Labeling | Approved | None posted |
| May 10, 1989 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1989 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1989 | Supplement 27Labeling | Approved | None posted |
| Jan 18, 1989 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1989 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1988 | Supplement 25Labeling | Approved | None posted |
| Oct 20, 1988 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1988 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1988 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1988 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1987 | Supplement 19Labeling | Approved | None posted |
| Jun 15, 1987 | Supplement 6Labeling | Approved | None posted |
| Jun 15, 1987 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 15, 1987 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 24, 1987 | Supplement 3Labeling | Approved | None posted |
| Jan 28, 1987 | Supplement 11Labeling | Approved | None posted |
| Jan 28, 1987 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1987 | Supplement 9Labeling | Approved | None posted |
| Jan 28, 1987 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Nov 18, 1986 | Supplement 12Labeling | Approved | None posted |
| Oct 28, 1986 | Supplement 7Labeling | Approved | None posted |
| Jun 10, 1986 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 14, 1986 | Original applicationNew active ingredient · Standard review | Approved | None posted |
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
