Mitosol
These highlights do not include all the information needed to use MITOSOL safely and effectively. See full prescribing information for MITOSOL. MITOSOL (mitomycin for solution) for ophthalmic useInitial U.S. Approval: 1974
Approved
Approval ID
244002c6-c61d-43fe-9326-072797113979
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Mobius Therapeutics LLC
DUNS: 805642118
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 Code49771-002
Application NumberNDA022572
Product Classification
M
Marketing Category
C73594
G
Generic Name
mitomycin
Product Specifications
Effective DateDecember 15, 2022
FDA Product Classification