General MedicationsORALStandard

TUXARIN ER

CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

Standard Dose

8MG;54.3MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview TUXARIN ER is listed in Drugs@FDA under application 206323 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 8MG;54.3MG Sponsor MAINPOINTE Submission history Latest submission status date: 2023-12-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview TUXARIN ER is listed in Drugs@FDA under application 206323 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 8MG;54.3MG Sponsor MAINPOINTE Submission history Latest submission status date: 2023-12-15 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.