APPLICATION
NDA016008
TYPE
NDA
ORIGINAL APPROVAL
1965-04-07
LATEST ACTION
2000-05-19
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
PERMITILDiscontinued
FLUPHENAZINE HYDROCHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CONCENTRATE · ORAL
Approval history
2000-05-19Labeling · Supplement 13 · standardAP
1999-07-26Manufacturing (CMC) · Supplement 17 · standardAP
1989-07-28Manufacturing (CMC) · Supplement 11 · standardAP
1989-04-13Manufacturing (CMC) · Supplement 15 · standardAP
1989-04-13Manufacturing (CMC) · Supplement 16 · standardAP
1988-10-04Manufacturing (CMC) · Supplement 14 · standardAP
1987-02-26Manufacturing (CMC) · Supplement 10 · standardAP
1986-09-11Manufacturing (CMC) · Supplement 12 · standardAP
1982-04-19Manufacturing (CMC) · Supplement 8 · standardAP
1965-04-07Type 3 - New Dosage Form · 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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