APPLICATION
ANDA078347
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-14
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 22 · standardAP
2025-01-16Labeling · Supplement 16 · standardAP
2019-10-09Labeling · Supplement 13 · standardAP
2018-06-08Labeling · Supplement 8 · standardAP
2018-06-08Labeling · Supplement 11 · standardAP
2018-06-08Labeling · Supplement 7 · standardAP
2010-12-03Labeling · Supplement 1AP
2009-09-14OriginalAP
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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