APPLICATION
ANDA089556
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-16
LATEST ACTION
2025-01-22
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUPHENAZINE HYDROCHLORIDEPrescription
FLUPHENAZINE HYDROCHLORIDE 2.5MG/ML · INJECTABLE · INJECTION
Approval history
2025-01-22Labeling · Supplement 27 · standardAP
2017-02-23Labeling · Supplement 19 · standardAP
2010-12-03Labeling · Supplement 16AP
2009-07-21Labeling · Supplement 14AP
2008-11-18Labeling · Supplement 12AP
2002-12-05Manufacturing (CMC) · Supplement 8AP
2001-10-15Manufacturing (CMC) · Supplement 7AP
1998-09-01Manufacturing (CMC) · Supplement 5AP
1995-01-20Manufacturing (CMC) · Supplement 4AP
1987-04-16OriginalAP
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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