APPLICATION
ANDA040521
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-08
LATEST ACTION
2023-09-19
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
PHENYTOINPrescription
PHENYTOIN 125MG/5ML · SUSPENSION · ORAL
Approval history
2023-09-19Labeling · Supplement 19 · standardAP
2023-09-19Labeling · Supplement 13 · standardAP
2023-09-19Labeling · Supplement 11 · standardAP
2023-09-19Labeling · Supplement 16 · standardAP
2023-09-19Labeling · Supplement 22 · standardAP
2023-09-19Labeling · Supplement 20 · standardAP
2023-09-19Labeling · Supplement 12 · standardAP
2023-09-19Labeling · Supplement 10 · standardAP
2023-09-19Labeling · Supplement 9 · standardAP
2015-03-20Labeling · Supplement 7 · standardAP
2014-01-16Labeling · Supplement 5 · standardAP
2014-01-16Labeling · Supplement 3AP
2014-01-16Labeling · Supplement 4AP
2009-12-15Labeling · Supplement 1AP
2004-03-08OriginalAP
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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