APPLICATION
ANDA073364
TYPE
ANDA
ORIGINAL APPROVAL
1993-09-28
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
HALOPERIDOLPrescription
HALOPERIDOL LACTATE EQ 2MG BASE/ML · CONCENTRATE · ORAL
Approval history
2025-01-22Labeling · Supplement 15 · standardAP
2017-02-23Labeling · Supplement 11 · standardAP
2010-12-03Labeling · Supplement 9AP
2009-04-30Labeling · Supplement 8AP
2002-01-10Labeling · Supplement 4AP
2000-09-22Manufacturing (CMC) · Supplement 3AP
1998-09-08Manufacturing (CMC) · Supplement 2AP
1998-07-27Manufacturing (CMC) · Supplement 1AP
1993-09-28OriginalAP
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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