MedPath
FDA Product

FOSPHENYTOIN SODIUM

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

Basic Information

FOSPHENYTOIN SODIUM

64679-730

Regulatory Information

64679-730

ANDA078137

C73584

December 29, 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 use Initial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

Wockhardt USA LLC.

170508365

Active Ingredients

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TROMETHAMINE

Code: 023C2WHX2V

Class Code: IACT

FOSPHENYTOIN SODIUM

Quantity: 50 mg in 1 mL

Code: 7VLR55452Z

Class Code: ACTIR

Active Moieties

PHENYTOIN

Code: 6158TKW0C5

© Copyright 2025. All Rights Reserved by MedPath