APPLICATION
ANDA076464
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-29
LATEST ACTION
2025-01-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HALOPERIDOLDiscontinued
HALOPERIDOL LACTATE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-01-22Labeling · Supplement 4 · standardAP
2013-07-31Labeling · Supplement 2AP
2004-09-29OriginalAP
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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