APPLICATION
NDA016727
TYPE
NDA
ORIGINAL APPROVAL
1972-06-20
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROLIXIN DECANOATE · ReferenceDiscontinued
FLUPHENAZINE DECANOATE 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2009-03-13Labeling · Supplement 11AP
2009-03-13Labeling · Supplement 46AP
2009-03-13Labeling · Supplement 38AP
2009-03-13Labeling · Supplement 8AP
2009-03-13Labeling · Supplement 6AP
2009-03-13Labeling · Supplement 40AP
2009-03-13Labeling · Supplement 14AP
2009-03-13Labeling · Supplement 45AP
2009-03-13Labeling · Supplement 35AP
2009-03-13Labeling · Supplement 41AP
2009-03-13Labeling · Supplement 23AP
2002-10-04Manufacturing (CMC) · Supplement 53 · standardAP
2001-09-17Manufacturing (CMC) · Supplement 52 · standardAP
1996-02-15Manufacturing (CMC) · Supplement 49 · standardAP
1994-08-16Manufacturing (CMC) · Supplement 51 · standardAP
1994-08-11Manufacturing (CMC) · Supplement 50 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 48 · standardAP
1987-06-15Manufacturing (CMC) · Supplement 42 · standardAP
1987-06-15Manufacturing (CMC) · Supplement 43 · standardAP
1986-09-19Manufacturing (CMC) · Supplement 39 · standardAP
1985-10-23Manufacturing (CMC) · Supplement 37 · standardAP
1985-05-30Manufacturing (CMC) · Supplement 30 · standardAP
1985-02-12Manufacturing (CMC) · Supplement 36 · standardAP
1984-12-21Manufacturing (CMC) · Supplement 31 · standardAP
1984-06-29Labeling · Supplement 34AP
1984-05-11Manufacturing (CMC) · Supplement 32 · standardAP
1983-05-03Manufacturing (CMC) · Supplement 29 · standardAP
1982-08-04Labeling · Supplement 28AP
1982-08-04Labeling · Supplement 27AP
1982-02-04Manufacturing (CMC) · Supplement 26 · standardAP
1981-09-10Manufacturing (CMC) · Supplement 24 · standardAP
1981-04-16Manufacturing (CMC) · Supplement 22 · standardAP
1981-03-23Manufacturing (CMC) · Supplement 21 · standardAP
1981-01-09Labeling · Supplement 20AP
1980-04-28Labeling · Supplement 19AP
1980-01-04Manufacturing (CMC) · Supplement 15 · standardAP
1979-12-20Labeling · Supplement 16AP
1979-12-20Labeling · Supplement 17AP
1979-02-06Labeling · Supplement 10AP
1978-11-21Manufacturing (CMC) · Supplement 9 · 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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