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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 078277

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NDA 078277 describes FOSPHENYTOIN SODIUM, which is a drug marketed by Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Norvium Bioscience, Sun Pharm, and Wockhardt, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the FOSPHENYTOIN SODIUM profile page.

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

Summary for 078277

Tradename:	FOSPHENYTOIN SODIUM
Applicant:	Am Regent
Ingredient:	fosphenytoin sodium
Patents:	0

Profile for product number 001

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

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