Tuzistra Xr

NDA 207768, held by Tris Pharma Inc. Chlorpheniramine Polistirex; Codeine Polistirex.

As of Nov 15, 2026, NDA 207768 (Tuzistra Xr), held by Tris Pharma Inc, was first approved by FDA on Apr 30, 2015, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2015
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 30, 2015	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tuzistra XrEQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML · suspension, extended release;oral	Chlorpheniramine Polistirex; Codeine Polistirex	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 14Labeling · Standard review	Approved	Label Letter Letter
Dec 15, 2023	Supplement 13Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 28, 2018	Supplement 7Labeling · Standard review	Approved	Letter Label
Aug 29, 2017	Supplement 6Labeling · Standard review	Approved	Letter Label
Feb 17, 2017	Supplement 3Manufacturing	Approved	None posted
Jan 13, 2017	Supplement 4Labeling · Standard review	Approved	Letter Label
Feb 19, 2016	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 4, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 30, 2015	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 207768
Drugs@FDA: Overview at FDA
Company: Tris Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters