APPLICATION
ANDA089742
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-25
LATEST ACTION
2010-12-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLUPHENAZINE HYDROCHLORIDEPrescription
FLUPHENAZINE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2010-12-03Labeling · Supplement 26AP
2010-03-12Labeling · Supplement 24AP
2009-01-23Labeling · Supplement 23AP
2008-07-25Labeling · Supplement 22AP
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 14AP
1997-11-26Manufacturing (CMC) · Supplement 15AP
1997-07-09Manufacturing (CMC) · Supplement 13AP
1994-08-31Manufacturing (CMC) · Supplement 12AP
1993-11-26Manufacturing (CMC) · Supplement 10AP
1993-08-27Labeling · Supplement 11AP
1990-01-23Bioequivalence · Supplement 7AP
1988-12-19Bioequivalence · Supplement 1AP
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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