General MedicationsORALGeneric

TUZISTRA XR

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

Standard Dose

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

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview TUZISTRA XR is listed in Drugs@FDA under application 207768 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML Sponsor TRIS PHARMA INC Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview TUZISTRA XR is listed in Drugs@FDA under application 207768 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML Sponsor TRIS PHARMA INC Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.