APPLICATION
ANDA075440
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-28
LATEST ACTION
2025-08-18
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HALOPERIDOL DECANOATEPrescription
HALOPERIDOL DECANOATE EQ 100MG BASE/ML · INJECTABLE · INJECTION
HALOPERIDOL DECANOATEPrescription
HALOPERIDOL DECANOATE EQ 50MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-08-18Labeling · Supplement 55 · standardAP
2021-08-23Labeling · Supplement 49 · standardAP
2019-12-23Labeling · Supplement 40 · standardAP
2019-12-23Labeling · Supplement 45 · standardAP
2019-12-23Labeling · Supplement 41 · standardAP
2016-09-19Labeling · Supplement 36 · standardAP
2016-09-19Labeling · Supplement 39 · standardAP
2011-11-30Labeling · Supplement 32AP
2010-02-26Labeling · Supplement 31AP
2009-01-29Labeling · Supplement 30AP
2008-08-19Labeling · Supplement 29AP
2008-04-28Labeling · Supplement 26AP
2007-02-09Labeling · Supplement 21AP
2005-02-11Labeling · Supplement 13AP
2005-02-11Supplement · Supplement 11AP
2005-02-11Supplement · Supplement 12AP
2005-02-11Supplement · Supplement 10AP
2002-11-26Manufacturing (CMC) · Supplement 5AP
2002-06-24Manufacturing (CMC) · Supplement 3AP
2002-01-02Manufacturing (CMC) · Supplement 4AP
2001-11-19Labeling · Supplement 1AP
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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