APPLICATION
ANDA074893
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-19
LATEST ACTION
2025-07-01
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
2025-07-01Labeling · Supplement 29 · standardAP
2025-06-20Labeling · Supplement 24 · standardAP
2025-06-20Labeling · Supplement 22 · standardAP
2025-06-20Labeling · Supplement 23 · standardAP
2016-06-30Labeling · Supplement 19 · standardAP
2012-05-22Labeling · Supplement 17AP
2011-09-27Labeling · Supplement 16AP
2009-03-14Labeling · Supplement 13AP
2008-10-30Labeling · Supplement 12AP
2002-12-05Manufacturing (CMC) · Supplement 4AP
1999-11-19Manufacturing (CMC) · Supplement 2AP
1999-01-21Manufacturing (CMC) · Supplement 1AP
1997-12-19OriginalAP
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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