APPLICATION
ANDA076886
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-06
LATEST ACTION
2020-12-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FOSPHENYTOIN SODIUMDiscontinued
FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML · INJECTABLE · INJECTION
Approval history
2020-12-17Labeling · Supplement 9 · standardAP
2020-12-17Labeling · Supplement 10 · standardAP
2020-12-17Labeling · Supplement 11 · 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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