APPLICATION
ANDA070533
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-07
LATEST ACTION
1996-03-04
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
PROLIXINDiscontinued
FLUPHENAZINE HYDROCHLORIDE 5MG/ML · CONCENTRATE · ORAL
Approval history
1996-03-04Manufacturing (CMC) · Supplement 11AP
1993-04-16Manufacturing (CMC) · Supplement 10AP
1987-10-05Labeling · Supplement 8AP
1987-10-05Labeling · Supplement 6AP
1987-10-05Labeling · Supplement 7AP
1987-03-10Labeling · Supplement 5AP
1986-06-06Manufacturing (CMC) · Supplement 4AP
1986-03-25Labeling · Supplement 3AP
1986-03-20Manufacturing (CMC) · Supplement 1AP
1986-03-20Labeling · Supplement 2AP
1985-11-07OriginalAP
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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