APPLICATION
ANDA075918
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-17
LATEST ACTION
2025-01-22
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUPHENAZINE DECANOATEPrescription
FLUPHENAZINE DECANOATE 25MG/ML · INJECTABLE · INJECTION
Approval history
2025-01-22Labeling · Supplement 27 · standardAP
2024-12-20Labeling · Supplement 21 · standardAP
2011-12-21Labeling · Supplement 19AP
2010-12-03Labeling · Supplement 18AP
2008-08-19Labeling · Supplement 17AP
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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