APPLICATION
ANDA085787
TYPE
ANDA
ORIGINAL APPROVAL
1982-04-15
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
TRIFLUOPERAZINE HYDROCHLORIDEDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 10MG BASE/ML · CONCENTRATE · ORAL
Approval history
2025-01-22Labeling · Supplement 33 · standardAP
2025-01-14Labeling · Supplement 32 · standardAP
2015-03-19Labeling · Supplement 31AP
1994-01-24Manufacturing (CMC) · Supplement 30AP
1992-07-29Labeling · Supplement 29AP
1989-10-11Labeling · Supplement 34AP
1989-10-10Labeling · Supplement 25AP
1989-09-15Labeling · Supplement 26AP
1988-03-16Manufacturing (CMC) · Supplement 21AP
1988-03-16Manufacturing (CMC) · Supplement 22AP
1986-07-30Manufacturing (CMC) · Supplement 17AP
1984-08-03Manufacturing (CMC) · Supplement 14AP
1984-05-02Manufacturing (CMC) · Supplement 12AP
1984-04-13Manufacturing (CMC) · Supplement 11AP
1984-02-01Manufacturing (CMC) · Supplement 9AP
1983-05-19Manufacturing (CMC) · Supplement 8AP
1982-12-09Manufacturing (CMC) · Supplement 6AP
1982-12-09Manufacturing (CMC) · Supplement 7AP
1982-12-09Manufacturing (CMC) · Supplement 5AP
1982-10-28Manufacturing (CMC) · Supplement 3AP
1982-09-22Manufacturing (CMC) · Supplement 4AP
1982-04-15OriginalAP
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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