Tuzistra XR FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 27, 2024.
FDA Approved: Yes (Discontinued) (First approved April 30, 2015)
Brand name: Tuzistra XR
Generic name: chlorpheniramine polistirex and codeine polistirex
Dosage form: Extended Release Oral Suspension
Company: Tris Pharma, Inc.
Treatment for: Cold Symptoms, Cough
Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) is an extended-release opiate agonist antitussive and histamine-1 (H1) receptor antagonist combination indicated for the relief of cough and symptoms associated with upper respiratory allergies or the common cold.
- The marketing end date for Tuzistra XR was January 31, 2023.
Development timeline for Tuzistra XR
Date | Article |
---|---|
May 1, 2015 | Approval Vernalis and Tris Pharma Receive FDA Approval for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) |
Sep 15, 2014 | FDA accepts Tuzistra XR (CCP-01) NDA for full review |
Further information
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