General MedicationsORALStandard
EXXUA
GEPIRONE HYDROCHLORIDE
Standard Dose
EQ 18.2MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview EXXUA is listed in Drugs@FDA under application 021164 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GEPIRONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 18.2MG BASE Sponsor FABRE KRAMER Submission history Latest submission status date: 2025-06-07 00:00:00.
Structured Monograph
Clinical summary
Approval overview EXXUA is listed in Drugs@FDA under application 021164 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GEPIRONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 18.2MG BASE Sponsor FABRE KRAMER Submission history Latest submission status date: 2025-06-07 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.