APPLICATION
ANDA071235
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-03
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HALOPERIDOLDiscontinued
HALOPERIDOL 5MG · TABLET · ORAL
HALOPERIDOLDiscontinued
HALOPERIDOL 0.5MG · TABLET · ORAL
HALOPERIDOLDiscontinued
HALOPERIDOL 10MG · TABLET · ORAL
HALOPERIDOLDiscontinued
HALOPERIDOL 1MG · TABLET · ORAL
HALOPERIDOLDiscontinued
HALOPERIDOL 2MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 19 · standardAP
2017-02-23Labeling · Supplement 16 · standardAP
2015-03-18Labeling · Supplement 15AP
1998-04-30Manufacturing (CMC) · Supplement 14AP
1993-10-27Labeling · Supplement 13AP
1989-03-09Labeling · Supplement 12AP
1987-11-20Manufacturing (CMC) · Supplement 4AP
1987-09-15Manufacturing (CMC) · Supplement 3AP
1987-07-02Manufacturing (CMC) · Supplement 2AP
1987-05-11Manufacturing (CMC) · Supplement 1AP
1986-11-03OriginalAP
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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