Orange Book product · Brand (NDA)

TUZISTRA XR

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

Brand (NDA)NDA 207768DISCN TRIS PHARMA INC

Apr 30, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 30, 2015
11 yr 4 mo ago
Today
Patent 8790700 expires
Listed drug product patent expiration.
Mar 15, 2027
in 9 mo
Patent 8062667 expires
Listed drug product patent expiration.
Mar 29, 2029
in 2 yr 10 mo

Active ingredient

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

Strength

EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 207768

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
8790700	Mar 15, 2027	in 9 mo	Product
8062667	Mar 29, 2029	in 2 yr 10 mo	Product