FDA ANDA · ANDA074531

FLUPHENAZINE DECANOATE

Sponsor: HIKMA

APPLICATION

ANDA074531

TYPE

ANDA

ORIGINAL APPROVAL

1996-08-30

LATEST ACTION

2025-02-19

ROUTE

INTRAMUSCULAR, SUBCUTANEOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

FLUPHENAZINE DECANOATEPrescription

FLUPHENAZINE DECANOATE 25MG/ML · INJECTABLE · INJECTION

2025-02-19Labeling · Supplement 20 · standardAP

2017-02-23Labeling · Supplement 15 · standardAP

2013-10-17Labeling · Supplement 13 · standardAP

2010-12-03Labeling · Supplement 9AP

2009-05-22Labeling · Supplement 8AP

2008-10-30Labeling · Supplement 7AP

2008-08-19Labeling · Supplement 6AP

2001-04-03Manufacturing (CMC) · Supplement 1 — Review ↗AP

1996-08-30Original — Other ↗AP

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

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