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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040435

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NDA 040435 describes EXTENDED PHENYTOIN SODIUM, which is a drug marketed by Amneal Pharms Ny, Ani Pharms, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Unichem, Wockhardt, and Wockhardt Usa, and is included in eleven NDAs. It is available from eleven suppliers. Additional details are available on the EXTENDED PHENYTOIN SODIUM profile page.

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

Summary for 040435

Tradename:	EXTENDED PHENYTOIN SODIUM
Applicant:	Ani Pharms
Ingredient:	phenytoin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG EXTENDED
Approval Date:	Jun 20, 2003	TE:		RLD:	No

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