APPLICATION
ANDA078765
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-02
LATEST ACTION
2018-03-08
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FOSPHENYTOIN SODIUMPrescription
FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML · INJECTABLE · INJECTION
Approval history
2018-03-08Labeling · Supplement 9 · standardAP
2018-03-08Labeling · Supplement 7 · standardAP
2018-03-08Labeling · Supplement 8 · standardAP
2013-08-14Labeling · Supplement 5AP
2009-12-02OriginalAP
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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