APPLICATION
ANDA089585
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-16
LATEST ACTION
2011-10-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLUPHENAZINE HYDROCHLORIDEPrescription
FLUPHENAZINE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2011-10-19Labeling · Supplement 22AP
2010-12-03Labeling · Supplement 21AP
2009-07-07Labeling · Supplement 19AP
2009-01-23Labeling · Supplement 18AP
2008-05-29Labeling · Supplement 14AP
1999-05-05Manufacturing (CMC) · Supplement 9AP
1998-10-08Labeling · Supplement 7AP
1998-10-08Manufacturing (CMC) · Supplement 6AP
1998-09-15Manufacturing (CMC) · Supplement 8AP
1995-10-20Manufacturing (CMC) · Supplement 5AP
1995-02-02Manufacturing (CMC) · Supplement 4AP
1988-11-01Manufacturing (CMC) · Supplement 2AP
1988-11-01Labeling · Supplement 3AP
1988-11-01Labeling · Supplement 1AP
1987-10-16OriginalAP
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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