APPLICATION
ANDA204849
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-06
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
2023-06-23Labeling · Supplement 3 · standardAP
2020-02-14Labeling · Supplement 1 · 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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