General MedicationsORALStandard

AUVELITY

BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

Standard Dose

105MG;45MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview AUVELITY is listed in Drugs@FDA under application 215430 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 105MG;45MG Sponsor AXSOME Submission history Latest submission status date: 2025-11-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview AUVELITY is listed in Drugs@FDA under application 215430 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 105MG;45MG Sponsor AXSOME Submission history Latest submission status date: 2025-11-05 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.