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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

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Mitosol - FDA Drug Approval Details