Orange Book product · Brand (NDA)

ZUPLENZ

ONDANSETRON

Brand (NDA)NDA 022524DISCN AQUESTIVE

Jul 02, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 02, 2010
16 yr 2 mo ago
Today
Patent 8580830 expires
Listed drug product patent expiration.
Nov 23, 2029
in 3 yr 6 mo
Patent 9095577 expires
Listed drug product patent expiration.
Jul 13, 2030
in 4 yr 2 mo

Active ingredient

ONDANSETRON

Strength

4MG

Dosage form

FILM

Route

ORAL

TE code

Not listed

Application

NDA 022524

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8580830	Nov 23, 2029	in 3 yr 6 mo	Product
9095577	Jul 13, 2030	in 4 yr 2 mo	Product