Last Updated: September 24, 2026

Details for New Drug Application (NDA): 077481

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NDA 077481 describes FOSPHENYTOIN SODIUM, which is a drug marketed by Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland, Hikma, Hikma Farmaceutica, Hospira, Pharmobedient, Sun Pharm, and Wockhardt Bio Ag, and is included in fourteen NDAs. It is available from seven suppliers. Additional details are available on the FOSPHENYTOIN SODIUM profile page.

The generic ingredient in FOSPHENYTOIN SODIUM is fosphenytoin sodium. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

Summary for 077481

Tradename:	FOSPHENYTOIN SODIUM
Applicant:	Hikma
Ingredient:	fosphenytoin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG PHENYTOIN NA/ML
Approval Date:	Aug 6, 2007	TE:	AP	RLD:	No

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