APPLICATION
ANDA078537
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-06
LATEST ACTION
2020-12-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FOMEPIZOLEPrescription
FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) · INJECTABLE · INJECTION
Approval history
2020-12-23Labeling · Supplement 8 · standardAP
2016-04-22Manufacturing (CMC) · Supplement 4 · unknownAP
2015-03-18Labeling · Supplement 2AP
2008-03-06OriginalAP
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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