APPLICATION
ANDA078052
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-06
LATEST ACTION
2020-08-28
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FOSPHENYTOIN SODIUMPrescription
FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML · INJECTABLE · INJECTION
Approval history
2020-08-28Labeling · Supplement 15 · standardAP
2019-11-04Labeling · Supplement 12 · standardAP
2019-11-04Labeling · Supplement 10 · standardAP
2019-11-04Labeling · Supplement 8 · standardAP
2019-11-04Labeling · Supplement 11 · standardAP
2016-05-16Labeling · Supplement 7 · standardAP
2016-01-30Labeling · Supplement 5 · standardAP
2016-01-30Labeling · Supplement 3 · standardAP
2016-01-30Labeling · Supplement 6 · standardAP
2016-01-30Labeling · Supplement 4 · standardAP
2013-08-22Labeling · Supplement 2 · standardAP
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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