APPLICATION
ANDA040298
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-28
LATEST ACTION
2024-02-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued
Products
PHENYTEKPrescription
PHENYTOIN SODIUM 200MG EXTENDED · CAPSULE · ORAL
PHENYTEKPrescription
PHENYTOIN SODIUM 300MG EXTENDED · CAPSULE · ORAL
EXTENDED PHENYTOIN SODIUMDiscontinued
PHENYTOIN SODIUM 100MG EXTENDED · CAPSULE · ORAL
Approval history
2024-02-01Labeling · Supplement 38 · standardAP
2024-02-01Labeling · Supplement 44 · standardAP
2024-02-01Labeling · Supplement 36 · standardAP
2024-02-01Labeling · Supplement 47 · standardAP
2024-02-01Labeling · Supplement 41 · standardAP
2016-12-27Labeling · Supplement 33 · standardAP
2016-12-27Labeling · Supplement 31 · standardAP
2014-01-08Labeling · Supplement 28AP
2014-01-08Labeling · Supplement 30 · standardAP
2014-01-08Labeling · Supplement 29AP
2014-01-08Labeling · Supplement 25AP
2003-04-18Labeling · Supplement 17AP
2002-03-20Manufacturing (CMC) · Supplement 14AP
2002-03-20Manufacturing (CMC) · Supplement 12AP
2002-03-20Manufacturing (CMC) · Supplement 10AP
2002-03-20Manufacturing (CMC) · Supplement 15AP
2002-03-20Labeling · Supplement 13AP
2002-02-19Manufacturing (CMC) · Supplement 9AP
2002-01-17Manufacturing (CMC) · Supplement 3AP
2001-03-09Manufacturing (CMC) · Supplement 2AP
1999-09-10Labeling · Supplement 1AP
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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