APPLICATION
ANDA071210
TYPE
ANDA
ORIGINAL APPROVAL
1988-03-11
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HALOPERIDOLPrescription
HALOPERIDOL 10MG · 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
2002-12-11Manufacturing (CMC) · Supplement 19AP
2002-12-11Manufacturing (CMC) · Supplement 17AP
2002-12-11Manufacturing (CMC) · Supplement 18AP
2002-09-05Labeling · Supplement 16AP
2001-10-16Labeling · Supplement 12AP
2001-06-28Manufacturing (CMC) · Supplement 13AP
2001-06-14Manufacturing (CMC) · Supplement 14AP
2001-05-09Manufacturing (CMC) · Supplement 15AP
2000-10-31Manufacturing (CMC) · Supplement 11AP
2000-04-04Manufacturing (CMC) · Supplement 10AP
2000-01-06Manufacturing (CMC) · Supplement 8AP
1999-05-05Manufacturing (CMC) · Supplement 9AP
1998-09-21Manufacturing (CMC) · Supplement 6AP
1998-09-21Labeling · Supplement 7AP
1995-02-02Manufacturing (CMC) · Supplement 5AP
1990-04-20Labeling · Supplement 4AP
1989-06-01Labeling · Supplement 3AP
1988-09-09Labeling · Supplement 2AP
1988-04-26Manufacturing (CMC) · Supplement 1AP
1988-03-11OriginalAP
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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