APPLICATION
ANDA071413
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-14
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 29 · standardAP
2017-02-23Labeling · Supplement 25 · standardAP
2016-11-08Labeling · Supplement 24 · standardAP
2009-07-22Labeling · Supplement 18AP
2002-12-05Manufacturing (CMC) · Supplement 13AP
1997-02-28Labeling · Supplement 10AP
1997-02-28Manufacturing (CMC) · Supplement 9AP
1997-02-28Manufacturing (CMC) · Supplement 11AP
1987-07-14OriginalAP
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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