General MedicationsRECTALStandard
BUDESONIDE
BUDESONIDE
Standard Dose
2MG/ACTUATION
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BUDESONIDE is listed in Drugs@FDA under application 215328 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE Form and strength AEROSOL, FOAM;RECTAL - 2MG/ACTUATION Sponsor PADAGIS ISRAEL Submission history Latest submission status date: 2023-04-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview BUDESONIDE is listed in Drugs@FDA under application 215328 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE Form and strength AEROSOL, FOAM;RECTAL - 2MG/ACTUATION Sponsor PADAGIS ISRAEL Submission history Latest submission status date: 2023-04-12 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.