APPLICATION
ANDA071617
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-01
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
HALOPERIDOLDiscontinued
HALOPERIDOL LACTATE EQ 2MG BASE/ML · CONCENTRATE · ORAL
Approval history
2025-01-22Labeling · Supplement 34 · standardAP
2017-02-23Labeling · Supplement 32 · standardAP
2010-12-03Labeling · Supplement 28AP
2009-05-26Labeling · Supplement 27AP
2008-11-19Labeling · Supplement 26AP
2008-08-19Labeling · Supplement 25AP
2002-01-23Manufacturing (CMC) · Supplement 13AP
2001-10-31Manufacturing (CMC) · Supplement 17AP
2001-10-31Manufacturing (CMC) · Supplement 18AP
2001-10-31Manufacturing (CMC) · Supplement 19AP
2001-10-25Manufacturing (CMC) · Supplement 15AP
2001-10-25Manufacturing (CMC) · Supplement 16AP
2001-10-25Manufacturing (CMC) · Supplement 14AP
2001-02-26Manufacturing (CMC) · Supplement 12AP
2000-10-27Manufacturing (CMC) · Supplement 11AP
1999-06-17Manufacturing (CMC) · Supplement 9AP
1999-05-13Manufacturing (CMC) · Supplement 7AP
1999-03-23Manufacturing (CMC) · Supplement 8AP
1998-12-07Manufacturing (CMC) · Supplement 6AP
1997-06-02Labeling · Supplement 5AP
1996-05-31Manufacturing (CMC) · Supplement 4AP
1993-01-29Manufacturing (CMC) · Supplement 3AP
1992-10-21Manufacturing (CMC) · Supplement 1AP
1991-10-10Labeling · Supplement 2AP
1988-12-01OriginalAP
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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