General MedicationsORALStandard
AGAMREE
VAMOROLONE
Standard Dose
40MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview AGAMREE is listed in Drugs@FDA under application 215239 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient VAMOROLONE Form and strength SUSPENSION;ORAL - 40MG/ML Sponsor CATALYST PHARMS Submission history Latest submission status date: 2024-06-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview AGAMREE is listed in Drugs@FDA under application 215239 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient VAMOROLONE Form and strength SUSPENSION;ORAL - 40MG/ML Sponsor CATALYST PHARMS Submission history Latest submission status date: 2024-06-05 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.