APPLICATION
ANDA076035
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-29
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 27 · standardAP
2025-01-13Labeling · Supplement 26 · standardAP
2018-06-08Labeling · Supplement 24 · standardAP
2018-06-08Labeling · Supplement 23 · standardAP
2015-09-11Labeling · Supplement 21 · standardAP
2012-01-03Labeling · Supplement 14AP
2011-10-14Labeling · Supplement 6AP
2010-12-03Labeling · Supplement 9AP
2009-04-30Labeling · Supplement 4AP
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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