APPLICATION
ANDA071173
TYPE
ANDA
ORIGINAL APPROVAL
1988-01-07
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HALOPERIDOLPrescription
HALOPERIDOL 20MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 2MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 0.5MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 5MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 1MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 10MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 20 · standardAP
2017-04-26Labeling · Supplement 15 · standardAP
2010-12-03Labeling · Supplement 14AP
1998-12-01Manufacturing (CMC) · Supplement 13AP
1994-12-23Manufacturing (CMC) · Supplement 12AP
1994-10-11Manufacturing (CMC) · Supplement 11AP
1992-04-03Manufacturing (CMC) · Supplement 10AP
1992-04-03Manufacturing (CMC) · Supplement 8AP
1990-09-12Manufacturing (CMC) · Supplement 6AP
1990-09-12Labeling · Supplement 4AP
1990-09-12Manufacturing (CMC) · Supplement 3AP
1988-03-15Manufacturing (CMC) · Supplement 2AP
1988-03-15Manufacturing (CMC) · Supplement 1AP
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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