APPLICATION
ANDA040146
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-21
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Prescription
Products
FLUPHENAZINE HYDROCHLORIDEPrescription
FLUPHENAZINE HYDROCHLORIDE 2.5MG/5ML · ELIXIR · ORAL
Approval history
2025-01-22Labeling · Supplement 13 · standardAP
2017-02-23Labeling · Supplement 5 · standardAP
2010-12-03Labeling · Supplement 4AP
2009-12-03Labeling · Supplement 3AP
2009-03-12Labeling · Supplement 2AP
1996-08-21OriginalAP
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.