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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 085435

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NDA 085435 describes PHENYTOIN SODIUM, which is a drug marketed by Aurobindo Pharma, Pharmeral, Watson Labs, Acella, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott, and is included in sixteen NDAs. It is available from eleven suppliers. Additional details are available on the PHENYTOIN SODIUM profile page.

The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Summary for 085435

Tradename:	PHENYTOIN SODIUM
Applicant:	Pharmeral
Ingredient:	phenytoin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG PROMPT
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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