Human Drugs View

Product Information DR-XY47680_PI_01.pdf
Registration Number DR-XY47680
Generic Name Fosphenytoin Sodium
Brand Name Aurantin
Dosage Strength 75 mg/mL Solution for Injection (I.M./I.V.) [equivalent to Phenytoin sodium 50 mg/mL after administration]
Dosage Form Solution For Injection (IM/IV)
Classification Prescription Drug (RX)
Pharmacologic Category Antiepiletic (Hydantoin Derivative)
Packaging 10 mL USP/EP Type I clear and colorless glass vial enclosed with gray chlorobutyl rubber stopper (with Flurotec-coated bottom) and aluminium seal with aqua colored PP flip-off cap (Box of 10's)
Manufacturer Pharmacia and Upjohn Company LLC
Country of Origin United States of America
Trader
Importer Pfizer, Inc.
Distributor
Application Type Monitored Release (Compliance)
Issuance Date 20 January 2022
Expiry Date 20 January 2027