APPLICATION
ANDA089743
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-25
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLUPHENAZINE HYDROCHLORIDEPrescription
FLUPHENAZINE HYDROCHLORIDE 2.5MG · TABLET · ORAL
FLUPHENAZINE HYDROCHLORIDEPrescription
FLUPHENAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
FLUPHENAZINE HYDROCHLORIDEPrescription
FLUPHENAZINE HYDROCHLORIDE 5MG · TABLET · ORAL
FLUPHENAZINE HYDROCHLORIDEPrescription
FLUPHENAZINE HYDROCHLORIDE 1MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 38 · standardAP
2017-02-23Labeling · Supplement 28 · standardAP
2010-12-03Labeling · Supplement 25AP
2010-03-12Labeling · Supplement 23AP
2009-01-23Labeling · Supplement 22AP
2008-07-25Labeling · Supplement 21AP
2001-08-16Manufacturing (CMC) · Supplement 19AP
2001-04-12Manufacturing (CMC) · Supplement 18AP
1998-11-05Manufacturing (CMC) · Supplement 17AP
1998-01-16Manufacturing (CMC) · Supplement 16AP
1997-11-26Manufacturing (CMC) · Supplement 15AP
1997-11-26Manufacturing (CMC) · Supplement 14AP
1997-07-09Manufacturing (CMC) · Supplement 13AP
1994-08-31Manufacturing (CMC) · Supplement 12AP
1993-11-26Manufacturing (CMC) · Supplement 10AP
1993-08-27Labeling · Supplement 11AP
1992-11-10Bioequivalence · Supplement 8AP
1988-08-25OriginalAP
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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