APPLICATION
ANDA075689
TYPE
ANDA
ORIGINAL APPROVAL
2001-03-09
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 29 · standardAP
2025-01-13Labeling · Supplement 24 · standardAP
2025-01-13Labeling · Supplement 22 · standardAP
2018-06-08Labeling · Supplement 20 · standardAP
2015-09-15Labeling · Supplement 19 · standardAP
2015-09-15Labeling · Supplement 15AP
2011-09-27Labeling · Supplement 14AP
2010-12-06Labeling · Supplement 12AP
2009-03-14Labeling · Supplement 10AP
2008-10-30Labeling · Supplement 9AP
2002-12-05Manufacturing (CMC) · Supplement 3AP
2002-10-07Manufacturing (CMC) · Supplement 2AP
2001-06-24Manufacturing (CMC) · Supplement 1AP
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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