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FDA ANDA · ANDA040765
EXTENDED PHENYTOIN SODIUM
phenytoin sodium
Sponsor: AMNEAL PHARMS NY
APPLICATION
ANDA040765
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-12
LATEST ACTION
2023-08-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
EXTENDED PHENYTOIN SODIUMPrescription
PHENYTOIN SODIUM 100MG EXTENDED · CAPSULE · ORAL
Approval history
2023-08-03Labeling · Supplement 16 · standardAP
2023-08-03Labeling · Supplement 14 · standardAP
2023-08-03Labeling · Supplement 12 · standardAP
2023-08-03Labeling · Supplement 10 · standardAP
2023-08-03Labeling · Supplement 29 · standardAP
2023-08-03Labeling · Supplement 25 · standardAP
2023-08-03Labeling · Supplement 31 · standardAP
2023-08-03Labeling · Supplement 28 · standardAP
2014-01-03Labeling · Supplement 8AP
2014-01-03Labeling · Supplement 5AP
2013-12-31Labeling · Supplement 4AP
2008-11-12OriginalAP
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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