APPLICATION
ANDA073037
TYPE
ANDA
ORIGINAL APPROVAL
1993-02-26
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 22 · standardAP
2017-02-23Labeling · Supplement 15 · standardAP
2010-12-03Labeling · Supplement 14AP
2010-08-18Labeling · Supplement 13AP
2010-02-26Labeling · Supplement 12AP
2009-03-12Labeling · Supplement 11AP
2008-11-25Labeling · Supplement 10AP
1995-03-27Manufacturing (CMC) · Supplement 4AP
1995-01-31Manufacturing (CMC) · Supplement 2AP
1995-01-31Labeling · Supplement 3AP
1993-02-26OriginalAP
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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