APPLICATION
ANDA215509
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-30
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 1 · standardAP
2023-03-30UNKNOWN · Original · standardAP
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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