APPLICATION
ANDA089456
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-10
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PERPHENAZINEDiscontinued
PERPHENAZINE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 35 · standardAP
2017-02-23Labeling · Supplement 34 · standardAP
2017-02-10Labeling · Supplement 33 · standardAP
2002-09-20Manufacturing (CMC) · Supplement 19AP
2002-09-20Labeling · Supplement 20AP
2002-07-29Manufacturing (CMC) · Supplement 23AP
2002-03-12Manufacturing (CMC) · Supplement 22AP
2000-03-28Manufacturing (CMC) · Supplement 18AP
2000-01-28Manufacturing (CMC) · Supplement 17AP
1999-11-23Manufacturing (CMC) · Supplement 16AP
1999-08-20Manufacturing (CMC) · Supplement 15AP
1998-12-09Manufacturing (CMC) · Supplement 14AP
1997-05-30Manufacturing (CMC) · Supplement 13AP
1995-12-28Manufacturing (CMC) · Supplement 12AP
1995-06-28Manufacturing (CMC) · Supplement 9AP
1994-03-07Manufacturing (CMC) · Supplement 10AP
1993-11-19Manufacturing (CMC) · Supplement 11AP
1993-03-26Manufacturing (CMC) · Supplement 8AP
1992-04-08Manufacturing (CMC) · Supplement 7AP
1991-02-23Manufacturing (CMC) · Supplement 5AP
1990-12-04Labeling · Supplement 6AP
1987-11-20Manufacturing (CMC) · Supplement 3AP
1987-11-20Manufacturing (CMC) · Supplement 2AP
1987-09-28Manufacturing (CMC) · Supplement 1AP
1987-09-10OriginalAP
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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