APPLICATION
ANDA076774
TYPE
ANDA
ORIGINAL APPROVAL
2004-08-25
LATEST ACTION
2023-04-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HALOPERIDOLDiscontinued
HALOPERIDOL LACTATE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-04-18Labeling · Supplement 9 · standardAP
2018-06-08Labeling · Supplement 4 · standardAP
2018-06-08Labeling · Supplement 7 · standardAP
2018-06-08Labeling · Supplement 5 · standardAP
2004-08-25OriginalAP
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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