Orange Book product · Brand (NDA)

SYMPAZAN

CLOBAZAM

Brand (NDA)NDA 210833RX ASSERTIO SPECLTY

Nov 01, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 01, 2018
7 yr 9 mo ago
Today
Patent 12290597 expires
Listed drug product patent expiration.
Sep 05, 2039
in 13 yr 5 mo
Patent 12403090 expires
Listed drug product patent expiration.
Sep 05, 2039
in 13 yr 5 mo
Patent 11541002 expires
Listed drug product patent expiration.
Jan 31, 2040
in 13 yr 10 mo

Active ingredient

CLOBAZAM

Strength

5MG

Dosage form

FILM

Route

ORAL

TE code

Not listed

Application

NDA 210833

Product number

001

Marketing status

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
12290597	Sep 05, 2039	in 13 yr 5 mo	ProductU-724
12403090	Sep 05, 2039	in 13 yr 5 mo	ProductU-724
11541002	Jan 31, 2040	in 13 yr 10 mo	ProductU-724