General MedicationsORALStandard
APLENZIN
BUPROPION HYDROBROMIDE
Standard Dose
348MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview APLENZIN is listed in Drugs@FDA under application 022108 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BUPROPION HYDROBROMIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 348MG Sponsor BAUSCH Submission history Latest submission status date: 2025-11-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview APLENZIN is listed in Drugs@FDA under application 022108 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUPROPION HYDROBROMIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 348MG Sponsor BAUSCH 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.