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 11541002 expires
Listed drug product patent expiration.
Jan 31, 2040
in 13 yr 10 mo

Active ingredient

CLOBAZAM

Strength

20MG

Dosage form

FILM

Route

ORAL

TE code

Not listed

Application

NDA 210833

Product number

003

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
11541002	Jan 31, 2040	in 13 yr 10 mo	ProductU-724