General MedicationsORALStandard
ODOMZO
SONIDEGIB PHOSPHATE
Standard Dose
EQ 200MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ODOMZO is listed in Drugs@FDA under application 205266 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SONIDEGIB PHOSPHATE Form and strength CAPSULE;ORAL - EQ 200MG BASE Sponsor SUN PHARM Submission history Latest submission status date: 2023-08-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview ODOMZO is listed in Drugs@FDA under application 205266 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SONIDEGIB PHOSPHATE Form and strength CAPSULE;ORAL - EQ 200MG BASE Sponsor SUN PHARM Submission history Latest submission status date: 2023-08-22 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.