General MedicationsPYELOCALYCEALStandard
JELMYTO
MITOMYCIN
Standard Dose
40MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview JELMYTO is listed in Drugs@FDA under application 211728 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient MITOMYCIN Form and strength POWDER;PYELOCALYCEAL - 40MG/VIAL Sponsor UROGEN PHARMA Submission history Latest submission status date: 2024-10-04 00:00:00.
Structured Monograph
Clinical summary
Approval overview JELMYTO is listed in Drugs@FDA under application 211728 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MITOMYCIN Form and strength POWDER;PYELOCALYCEAL - 40MG/VIAL Sponsor UROGEN PHARMA Submission history Latest submission status date: 2024-10-04 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.