APPLICATION
NDA012034
TYPE
NDA
ORIGINAL APPROVAL
1959-09-09
LATEST ACTION
2002-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PERMITILDiscontinued
FLUPHENAZINE HYDROCHLORIDE 5MG · TABLET · ORAL
PERMITILDiscontinued
FLUPHENAZINE HYDROCHLORIDE 0.25MG · TABLET · ORAL
PERMITILDiscontinued
FLUPHENAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
PERMITILDiscontinued
FLUPHENAZINE HYDROCHLORIDE 2.5MG · TABLET · ORAL
Approval history
2002-11-12Labeling · Supplement 9AP
2002-11-12Labeling · Supplement 7AP
2002-11-12Labeling · Supplement 10AP
2002-11-12Labeling · Supplement 11AP
2002-11-12Labeling · Supplement 4AP
2000-05-19Labeling · Supplement 15AP
1999-10-18Manufacturing (CMC) · Supplement 18 · standardAP
1959-09-09Type 1 - New Molecular Entity · Original · standardAP
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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