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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 077648

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NDA 077648 describes ZONISAMIDE, which is a drug marketed by Ani Pharms, Apotex, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Inc, Granules, Invagen Pharms, Macleods Pharms Ltd, Pharmobedient, Rising, Roxane, Sun Pharm Inds (in), Sun Pharm Industries, Unichem, Upsher Smith Labs, and Zydus Lifesciences, and is included in nineteen NDAs. It is available from twenty suppliers. Additional details are available on the ZONISAMIDE profile page.

The generic ingredient in ZONISAMIDE is zonisamide. There are nineteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the zonisamide profile page.

Summary for 077648

Tradename:	ZONISAMIDE
Applicant:	Roxane
Ingredient:	zonisamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Dec 22, 2005	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Dec 22, 2005	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Dec 22, 2005	TE:		RLD:	No

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