APPLICATION
ANDA216730
TYPE
ANDA
ORIGINAL APPROVAL
2023-05-23
LATEST ACTION
2026-03-27
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
2026-03-27Labeling · Supplement 8 · standardAP
2025-07-24Labeling · Supplement 4 · standardAP
2023-05-23UNKNOWN · Original · standardAP
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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