← FDA DRUG APPROVALS

FDA ANDA · ANDA077580

HALOPERIDOL

Sponsor: ZYDUS PHARMS USA

APPLICATION
ANDA077580
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-29
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HALOPERIDOLPrescription
HALOPERIDOL 2MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 10MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 1MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 20MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 5MG · TABLET · ORAL
HALOPERIDOLPrescription
HALOPERIDOL 0.5MG · TABLET · ORAL

Approval history

2025-01-22Labeling · Supplement 19 · standardAP
2017-02-23Labeling · Supplement 12 · standardAP
2015-01-07Manufacturing (CMC) · Supplement 9AP
2011-09-27Labeling · Supplement 6AP
2010-12-06Labeling · Supplement 5AP
2008-11-25Labeling · Supplement 2AP
2008-05-29Labeling · Supplement 1AP
2007-11-29Original — Healthcare Professional Sheet ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →