APPLICATION
ANDA203732
TYPE
ANDA
ORIGINAL APPROVAL
2014-07-03
LATEST ACTION
2025-01-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUPHENAZINE DECANOATEPrescription
FLUPHENAZINE DECANOATE 25MG/ML · INJECTABLE · INJECTION
Approval history
2025-01-22Labeling · Supplement 13 · standardAP
2017-02-23Labeling · Supplement 4 · standardAP
2016-11-18Labeling · Supplement 3 · standardAP
2014-07-03UNKNOWN · OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.