JELMYTO
These highlights do not include all the information needed to use JELMYTO safely and effectively. See full prescribing information for JELMYTO. JELMYTO (mitomycin) for pyelocalyceal solution Initial U.S. Approval: 1974
Approved
Approval ID
3d3d5053-5427-4a68-a40b-edb60699521e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2022
Manufacturers
FDA
UroGen Pharma, Inc.
DUNS: 081130487
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mitomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72493-103
Application NumberNDA211728
Product Classification
M
Marketing Category
C73594
G
Generic Name
mitomycin
Product Specifications
Effective DateSeptember 1, 2022
FDA Product Classification