Orange Book product · Brand (NDA)

ZONISADE

ZONISAMIDE

Brand (NDA)NDA 214273RX AZURITY

Jul 15, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 15, 2022
4 yr ago
Today
Patent 11478456 expires
Listed method-of-use patent (U-3458) expiration.
Aug 18, 2038
in 12 yr 4 mo
Patent 11529333 expires
Listed drug product patent expiration.
Aug 18, 2038
in 12 yr 4 mo
Patent 12491179 expires
Listed drug product patent expiration.
Aug 18, 2038
in 12 yr 4 mo

Active ingredient

ZONISAMIDE

Strength

100MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 214273

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11478456	Aug 18, 2038	in 12 yr 4 mo	U-3458
11529333	Aug 18, 2038	in 12 yr 4 mo	Product
12491179	Aug 18, 2038	in 12 yr 4 mo	Product