APPLICATION
ANDA071209
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-17
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
HALOPERIDOLPrescription
HALOPERIDOL 1MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 5MG · TABLET · ORAL
HALOPERIDOLDiscontinued
HALOPERIDOL 2MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 0.5MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 37 · standardAP
2017-02-23Labeling · Supplement 33 · standardAP
2010-12-06Labeling · Supplement 29AP
2009-07-16Labeling · Supplement 27AP
2008-09-08Labeling · Supplement 26AP
2008-05-29Labeling · Supplement 23AP
2008-04-02Labeling · Supplement 22AP
2002-09-05Labeling · Supplement 20AP
2001-10-16Labeling · Supplement 17AP
2001-06-28Manufacturing (CMC) · Supplement 18AP
2001-05-09Manufacturing (CMC) · Supplement 19AP
2000-10-31Manufacturing (CMC) · Supplement 16AP
2000-04-04Manufacturing (CMC) · Supplement 15AP
2000-01-06Manufacturing (CMC) · Supplement 13AP
1999-05-05Manufacturing (CMC) · Supplement 14AP
1998-09-21Labeling · Supplement 12AP
1998-09-21Manufacturing (CMC) · Supplement 11AP
1995-02-02Manufacturing (CMC) · Supplement 10AP
1991-04-04Manufacturing (CMC) · Supplement 8AP
1990-04-20Labeling · Supplement 9AP
1990-04-20Labeling · Supplement 38AP
1989-06-01Labeling · Supplement 7AP
1988-09-09Labeling · Supplement 6AP
1987-10-28Manufacturing (CMC) · Supplement 3AP
1987-10-28Manufacturing (CMC) · Supplement 4AP
1987-10-28Manufacturing (CMC) · Supplement 2AP
1986-11-17OriginalAP
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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