APPLICATION
ANDA078476
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-18
LATEST ACTION
2022-08-24
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FOSPHENYTOIN SODIUMDiscontinued
FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML · INJECTABLE · INJECTION
Approval history
2022-08-24Labeling · Supplement 16 · standardAP
2022-08-24Labeling · Supplement 19 · standardAP
2021-02-17Labeling · Supplement 13 · standardAP
2019-10-21Labeling · Supplement 8 · standardAP
2019-10-21Labeling · Supplement 12 · standardAP
2019-10-21Labeling · Supplement 10 · standardAP
2019-10-21Labeling · Supplement 9 · standardAP
2015-10-15Labeling · Supplement 6 · standardAP
2015-04-15Labeling · Supplement 1 · standardAP
2015-04-15Labeling · Supplement 2 · standardAP
2015-04-15Labeling · Supplement 5 · standardAP
2015-04-15Labeling · Supplement 3 · standardAP
2008-03-18OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.