APPLICATION
ANDA074725
TYPE
ANDA
ORIGINAL APPROVAL
1996-09-16
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
FLUPHENAZINE HYDROCHLORIDEPrescription
FLUPHENAZINE HYDROCHLORIDE 5MG/ML · CONCENTRATE · ORAL
Approval history
2025-01-22Labeling · Supplement 13 · standardAP
2017-02-23Labeling · Supplement 5 · standardAP
2010-12-03Labeling · Supplement 4AP
2010-01-07Labeling · Supplement 3AP
2009-03-12Labeling · Supplement 2AP
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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