APPLICATION
ANDA075858
TYPE
ANDA
ORIGINAL APPROVAL
2001-06-18
LATEST ACTION
2025-01-22
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HALOPERIDOLPrescription
HALOPERIDOL LACTATE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-01-22Labeling · Supplement 28 · standardAP
2023-06-23Labeling · Supplement 23 · standardAP
2019-10-09Labeling · Supplement 22 · standardAP
2018-06-08Labeling · Supplement 21 · standardAP
2018-06-08Labeling · Supplement 20 · standardAP
2016-11-21Manufacturing (CMC) · Supplement 19 · unknownAP
2011-11-10Labeling · Supplement 14AP
2011-11-02Labeling · Supplement 13AP
2009-12-09Labeling · Supplement 11AP
2008-11-19Labeling · Supplement 10AP
2008-05-29Labeling · Supplement 9AP
2008-02-01Labeling · Supplement 8AP
2002-10-18Manufacturing (CMC) · Supplement 2AP
2002-09-04Manufacturing (CMC) · 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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