Tuzistra XR Approval History
FDA Approved: Yes (First approved April 30, 2015)
Brand name: Tuzistra XR
Generic name: chlorpheniramine polistirex and codeine polistirex
Dosage form: Extended Release Oral Suspension
Company: Vernalis plc and 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.
Development History and FDA Approval Process for Tuzistra XR
|May 1, 2015||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|
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