APPLICATION
ANDA070278
TYPE
ANDA
ORIGINAL APPROVAL
1986-06-10
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
HALOPERIDOLPrescription
HALOPERIDOL 10MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 5MG · TABLET · ORAL
HALOPERIDOLDiscontinued
HALOPERIDOL 20MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 2MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 0.5MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 1MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 43 · standardAP
2022-06-29Manufacturing (CMC) · Supplement 38 · unknownAP
2017-02-23Labeling · Supplement 32 · standardAP
2012-01-10Labeling · Supplement 29AP
2011-09-27Labeling · Supplement 28AP
2010-12-03Labeling · Supplement 27AP
2009-07-16Labeling · Supplement 24AP
2008-11-25Labeling · Supplement 25AP
2008-05-29Labeling · Supplement 22AP
2004-04-05Labeling · Supplement 17AP
2001-11-06Labeling · Supplement 16AP
2000-09-20Manufacturing (CMC) · Supplement 15AP
1998-02-25Manufacturing (CMC) · Supplement 13AP
1998-02-05Manufacturing (CMC) · Supplement 12AP
1994-10-14Manufacturing (CMC) · Supplement 11AP
1993-09-30Manufacturing (CMC) · Supplement 10AP
1989-08-30Labeling · Supplement 45AP
1989-08-30Labeling · Supplement 8AP
1989-07-11Manufacturing (CMC) · Supplement 7AP
1989-07-11Manufacturing (CMC) · Supplement 5AP
1989-05-08Labeling · Supplement 6AP
1988-03-28Manufacturing (CMC) · Supplement 3AP
1988-03-28Manufacturing (CMC) · Supplement 2AP
1988-03-07Labeling · Supplement 4AP
1986-06-10OriginalAP
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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