APPLICATION
ANDA089804
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-12
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FLUPHENAZINE HYDROCHLORIDEDiscontinued
FLUPHENAZINE HYDROCHLORIDE 5MG · TABLET · ORAL
FLUPHENAZINE HYDROCHLORIDEDiscontinued
FLUPHENAZINE HYDROCHLORIDE 1MG · TABLET · ORAL
FLUPHENAZINE HYDROCHLORIDEDiscontinued
FLUPHENAZINE HYDROCHLORIDE 2.5MG · TABLET · ORAL
FLUPHENAZINE HYDROCHLORIDEDiscontinued
FLUPHENAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 23 · standardAP
2017-02-23Labeling · Supplement 20 · standardAP
2010-12-03Labeling · Supplement 19AP
2009-05-26Labeling · Supplement 17AP
2008-09-18Labeling · Supplement 16AP
2008-08-19Labeling · Supplement 14AP
1998-12-21Manufacturing (CMC) · Supplement 9AP
1998-02-05Manufacturing (CMC) · Supplement 8AP
1995-05-10Labeling · Supplement 7AP
1995-05-10Manufacturing (CMC) · Supplement 5AP
1995-05-10Manufacturing (CMC) · Supplement 6AP
1993-10-07Manufacturing (CMC) · Supplement 4AP
1993-05-11Manufacturing (CMC) · Supplement 2AP
1990-01-31Manufacturing (CMC) · Supplement 1AP
1988-08-12OriginalAP
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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