APPLICATION
ANDA200742
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-02
LATEST ACTION
2025-01-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HALOPERIDOLPrescription
HALOPERIDOL LACTATE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-01-22Labeling · Supplement 7 · standardAP
2024-10-29Labeling · Supplement 6 · standardAP
2020-02-21Labeling · Supplement 5 · standardAP
2018-06-08Labeling · Supplement 3 · standardAP
2018-06-08Labeling · Supplement 4 · standardAP
2016-01-12Labeling · Supplement 2 · standardAP
2011-09-02Not Applicable · OriginalAP
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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