APPLICATION
ANDA200565
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-17
LATEST ACTION
2017-01-09
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
PHENYTOINPrescription
PHENYTOIN 50MG · TABLET, CHEWABLE · ORAL
Approval history
2017-01-09Labeling · Supplement 1 · standardAP
2017-01-09Labeling · Supplement 2 · standardAP
2014-04-17Not 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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