APPLICATION
NDA016110
TYPE
NDA
ORIGINAL APPROVAL
1967-03-15
LATEST ACTION
1992-01-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROLIXIN ENANTHATEDiscontinued
FLUPHENAZINE ENANTHATE 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1992-01-21Manufacturing (CMC) · Supplement 37 · priorityAP
1989-04-26Manufacturing (CMC) · Supplement 36 · priorityAP
1986-09-19Manufacturing (CMC) · Supplement 33 · priorityAP
1986-05-13Manufacturing (CMC) · Supplement 32 · priorityAP
1985-05-30Manufacturing (CMC) · Supplement 30 · priorityAP
1982-06-21Labeling · Supplement 29 · priorityAP
1982-02-04Manufacturing (CMC) · Supplement 28 · priorityAP
1981-09-11Manufacturing (CMC) · Supplement 26 · priorityAP
1981-07-31Manufacturing (CMC) · Supplement 25 · priorityAP
1981-05-14Manufacturing (CMC) · Supplement 24 · priorityAP
1981-03-23Manufacturing (CMC) · Supplement 22 · priorityAP
1981-01-09Labeling · Supplement 21 · priorityAP
1980-01-04Manufacturing (CMC) · Supplement 20 · priorityAP
1979-04-18Labeling · Supplement 19 · priorityAP
1978-12-15Manufacturing (CMC) · Supplement 16 · priorityAP
1977-12-08Manufacturing (CMC) · Supplement 15 · priorityAP
1967-03-15Type 2 - New Active Ingredient · Original · priorityAP
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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