Last Updated: November 8, 2026

Details for New Drug Application (NDA): 211633

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NDA 211633 describes EXTENDED PHENYTOIN SODIUM, which is a drug marketed by Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Lupin, Mankind Pharma, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Unichem, Wockhardt, and Wockhardt Usa, and is included in thirteen NDAs. It is available from seventeen suppliers. Additional details are available on the EXTENDED PHENYTOIN SODIUM profile page.

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

Summary for 211633

Tradename:	EXTENDED PHENYTOIN SODIUM
Applicant:	Lupin
Ingredient:	phenytoin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG EXTENDED
Approval Date:	Sep 30, 2019	TE:		RLD:	No

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