APPLICATION
ANDA200691
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-26
LATEST ACTION
2024-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
PHENYTOINPrescription
PHENYTOIN 50MG · TABLET, CHEWABLE · ORAL
Approval history
2024-09-27Labeling · Supplement 7 · standardAP
2024-09-27Labeling · Supplement 5 · standardAP
2024-09-27Labeling · Supplement 11 · standardAP
2024-09-27Labeling · Supplement 8 · standardAP
2017-01-06Labeling · Supplement 2 · standardAP
2017-01-06Labeling · Supplement 3 · standardAP
2012-12-26Not Applicable · OriginalAP
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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