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Tuzistra XR Approval History

  • FDA approved: Yes (First approved April 30th, 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, 2015Approval Vernalis and Tris Pharma Receive FDA Approval for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex)
Sep 15, 2014FDA accepts Tuzistra XR (CCP-01) NDA for full review

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