MedPath
FDA Product

Fosphenytoin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Fosphenytoin

63323-403

Regulatory Information

63323-403

ANDA078052

C73584

May 1, 2022

USA

These highlights do not include all the information needed to use FOSPHENYTOIN SODIUM INJECTION safely and effectively. See full prescribing information for FOSPHENYTOIN SODIUM INJECTION. FOSPHENYTOIN SODIUM injection, for intravenous or intramuscular useInitial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

14

Company Information

608775388

Active Ingredients

FOSPHENYTOIN SODIUM

Quantity: 50 mg in 1 mL

Code: 7VLR55452Z

Class Code: ACTIR

TROMETHAMINE

Code: 023C2WHX2V

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

PHENYTOIN

Code: 6158TKW0C5

© Copyright 2025. All Rights Reserved by MedPath