APPLICATION
ANDA070983
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-06
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HALOPERIDOLDiscontinued
HALOPERIDOL 2MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 14 · standardAP
2017-02-23Labeling · Supplement 13 · standardAP
2015-11-03Labeling · Supplement 12AP
1991-05-31Manufacturing (CMC) · Supplement 8AP
1990-11-19Labeling · Supplement 10AP
1990-11-19Manufacturing (CMC) · Supplement 9AP
1988-10-21Manufacturing (CMC) · Supplement 6AP
1988-10-21Manufacturing (CMC) · Supplement 5AP
1988-10-18Manufacturing (CMC) · Supplement 1AP
1987-03-06OriginalAP
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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