APPLICATION
ANDA078417
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-18
LATEST ACTION
2013-08-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FOSPHENYTOIN SODIUMPrescription
FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML · INJECTABLE · INJECTION
Approval history
2013-08-21Labeling · Supplement 2 · 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.
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