← FDA DRUG APPROVALS

FDA NDA · NDA018701

HALOPERIDOL DECANOATE

Sponsor: JANSSEN PHARMS

APPLICATION
NDA018701
TYPE
NDA
ORIGINAL APPROVAL
1986-01-14
LATEST ACTION
2025-10-30
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HALDOL · ReferenceDiscontinued
HALOPERIDOL DECANOATE EQ 50MG BASE/ML · INJECTABLE · INJECTION
HALDOL · ReferenceDiscontinued
HALOPERIDOL DECANOATE EQ 100MG BASE/ML · INJECTABLE · INJECTION

Approval history

2025-10-30Labeling · Supplement 77 · standard — Label ↗AP
2025-01-22Labeling · Supplement 78 · standard — Label ↗AP
2020-11-17Labeling · Supplement 71 · standard — Letter ↗AP
2020-11-17Labeling · Supplement 76 · standard — Letter ↗AP
2019-03-08Labeling · Supplement 73 · standard — Letter ↗AP
2017-12-05Labeling · Supplement 70 · standard — Letter ↗AP
2017-02-23Labeling · Supplement 74 · 901 required — Label ↗AP
2016-05-18Labeling · Supplement 72 · standard — Label ↗AP
2013-12-19Manufacturing (CMC) · Supplement 69 · standardAP
2013-06-05Manufacturing (CMC) · Supplement 68 · standardAP
2013-05-24Manufacturing (CMC) · Supplement 67 · standardAP
2013-05-06Labeling · Supplement 65 · standard — Letter ↗AP
2011-08-12Labeling · Supplement 54 · standard — Letter ↗AP
2011-03-01Labeling · Supplement 63 · standard — Letter ↗AP
2010-12-01Labeling · Supplement 62 · 901 required — Letter ↗AP
2009-07-19Labeling · Supplement 59 · 901 required — Label ↗AP
2008-08-14Labeling · Supplement 57 · standard — Letter ↗AP
2008-05-13Labeling · Supplement 56 · standard — Letter ↗AP
2007-09-19Labeling · Supplement 55 · standard — Letter ↗AP
2007-05-04Labeling · Supplement 53 · standard — Letter ↗AP
2002-04-17Labeling · Supplement 46 · standard — Review ↗AP
2000-05-02Labeling · Supplement 43 · standardAP
2000-04-13Manufacturing (CMC) · Supplement 45 · standardAP
1998-06-23Manufacturing (CMC) · Supplement 41 · standardAP
1997-09-11Manufacturing (CMC) · Supplement 40 · standardAP
1997-01-31Manufacturing (CMC) · Supplement 28 · standardAP
1997-01-31Labeling · Supplement 29AP
1996-05-10Manufacturing (CMC) · Supplement 39 · standardAP
1995-05-22Manufacturing (CMC) · Supplement 37 · standardAP
1994-09-07Manufacturing (CMC) · Supplement 38 · standardAP
1994-06-29Manufacturing (CMC) · Supplement 35 · standardAP
1993-04-27Labeling · Supplement 36 · standardAP
1993-04-21Labeling · Supplement 34AP
1990-12-21Manufacturing (CMC) · Supplement 33 · standardAP
1989-10-31Labeling · Supplement 32AP
1989-05-10Manufacturing (CMC) · Supplement 31 · standardAP
1989-02-16Manufacturing (CMC) · Supplement 30 · standardAP
1989-01-19Labeling · Supplement 27AP
1989-01-18Manufacturing (CMC) · Supplement 22 · standardAP
1989-01-18Manufacturing (CMC) · Supplement 23 · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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