MedPath
FDA Product

CEREBYX

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

Basic Information

CEREBYX

0069-5471

Regulatory Information

0069-5471

NDA020450

C73594

May 10, 2022

USA

These highlights do not include all the information needed to use CEREBYX safely and effectively. See full prescribing information for CEREBYX. CEREBYX (fosphenytoin sodium) injection, for intravenous or intramuscular use Initial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

28

Company Information

Pfizer Laboratories Div Pfizer Inc

134489525

Active Ingredients

FOSPHENYTOIN SODIUM

Quantity: 50 mg in 1 mL

Code: 7VLR55452Z

Class Code: ACTIR

WATER

Code: 059QF0KO0R

Class Code: IACT

TROMETHAMINE

Code: 023C2WHX2V

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

PHENYTOIN

Code: 6158TKW0C5

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