← FDA DRUG APPROVALS

FDA NDA · NDA015923

HALDOL

Sponsor: JANSSEN PHARMS

APPLICATION
NDA015923
TYPE
NDA
ORIGINAL APPROVAL
1971-05-18
LATEST ACTION
2020-11-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HALDOL · ReferenceDiscontinued
HALOPERIDOL LACTATE EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2020-11-17Labeling · Supplement 93 · standard — Letter ↗AP
2020-11-17Labeling · Supplement 98 · standard — Letter ↗AP
2019-03-08Labeling · Supplement 95 · standard — Letter ↗AP
2017-12-05Labeling · Supplement 92 · standard — Letter ↗AP
2017-02-23Labeling · Supplement 96 · 901 required — Label ↗AP
2016-05-18Labeling · Supplement 94 · standard — Letter ↗AP
2015-05-26Labeling · Supplement 91 · standard — Letter ↗AP
2013-05-06Labeling · Supplement 89 · standard — Letter ↗AP
2011-08-12Labeling · Supplement 79 · standard — Letter ↗AP
2011-03-01Labeling · Supplement 86 · unknown — Letter ↗AP
2010-12-01Labeling · Supplement 85 · 901 required — Letter ↗AP
2009-07-19Labeling · Supplement 84 · 901 required — Letter ↗AP
2008-08-14Labeling · Supplement 82 · standard — Label ↗AP
2008-05-13Labeling · Supplement 81 · standard — Letter ↗AP
2007-09-19Labeling · Supplement 80 · standard — Letter ↗AP
2007-05-04Labeling · Supplement 78 · standard — Letter ↗AP
2002-12-10Manufacturing (CMC) · Supplement 73 · standardAP
2002-04-17Labeling · Supplement 72 · standard — Review ↗AP
2000-11-07Manufacturing (CMC) · Supplement 71 · standardAP
2000-05-02Labeling · Supplement 66 · standardAP
2000-04-13Manufacturing (CMC) · Supplement 70 · standardAP
2000-03-16Manufacturing (CMC) · Supplement 69 · standardAP
2000-01-26Manufacturing (CMC) · Supplement 68 · standardAP
1998-04-23Manufacturing (CMC) · Supplement 62 · standardAP
1996-08-28Labeling · Supplement 54AP
1996-05-10Manufacturing (CMC) · Supplement 63 · standardAP
1995-01-30Manufacturing (CMC) · Supplement 59 · standardAP
1994-12-05Manufacturing (CMC) · Supplement 60 · standardAP
1994-06-29Manufacturing (CMC) · Supplement 58 · standardAP
1990-02-23Manufacturing (CMC) · Supplement 56 · standardAP
1990-02-14Manufacturing (CMC) · Supplement 55 · standardAP
1988-07-27Manufacturing (CMC) · Supplement 48 · standardAP
1988-06-02Manufacturing (CMC) · Supplement 52 · standardAP
1988-05-02Manufacturing (CMC) · Supplement 51 · standardAP
1988-04-25Manufacturing (CMC) · Supplement 47 · standardAP
1988-03-28Manufacturing (CMC) · Supplement 50 · standardAP
1988-02-12Manufacturing (CMC) · Supplement 49 · standardAP
1987-01-30Manufacturing (CMC) · Supplement 38 · standardAP
1987-01-30Manufacturing (CMC) · Supplement 40 · standardAP
1986-04-07Manufacturing (CMC) · Supplement 32 · 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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