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Last Updated: April 17, 2024

Details for New Drug Application (NDA): 020789

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NDA 020789 describes ZONEGRAN, which is a drug marketed by Concordia and is included in one NDA. It is available from one supplier. Additional details are available on the ZONEGRAN profile page.

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

Summary for 020789

Tradename:	ZONEGRAN
Applicant:	Concordia
Ingredient:	zonisamide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020789

Mechanism of Action	Carbonic Anhydrase Inhibitors P-Glycoprotein Inhibitors
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 020789

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZONEGRAN	zonisamide	CAPSULE;ORAL	020789	NDA	Concordia Pharmaceuticals Inc.	59212-680	59212-680-10	100 CAPSULE in 1 BOTTLE (59212-680-10)
ZONEGRAN	zonisamide	CAPSULE;ORAL	020789	NDA	Concordia Pharmaceuticals Inc.	59212-681	59212-681-10	100 CAPSULE in 1 BOTTLE (59212-681-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Mar 27, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 22, 2003	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Aug 22, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020789

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Concordia	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789-001	Mar 27, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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