APPLICATION
ANDA078736
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-08
LATEST ACTION
2023-11-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FOSPHENYTOIN SODIUMDiscontinued
FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML · INJECTABLE · INJECTION
Approval history
2023-11-28Labeling · Supplement 12 · standardAP
2023-11-28Labeling · Supplement 14 · standardAP
2020-12-23Labeling · Supplement 10 · standardAP
2019-11-06Labeling · Supplement 8 · standardAP
2019-11-06Labeling · Supplement 5 · standardAP
2016-11-09Labeling · Supplement 4 · standardAP
2016-06-24Labeling · Supplement 3 · standardAP
2013-08-16Labeling · Supplement 2 · standardAP
2010-06-08OriginalAP
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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