APPLICATION
ANDA218371
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-31
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
HALOPERIDOLPrescription
HALOPERIDOL LACTATE EQ 2MG BASE/ML · CONCENTRATE · ORAL
Approval history
2025-01-22Labeling · Supplement 1 · standardAP
2024-01-31UNKNOWN · Original · standardAP
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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