Mesna
These highlights do not include all the information needed to use MESNA INJECTION safely and effectively. See full prescribing information for MESNA INJECTION . MESNA injection, for intravenous use Initial U.S. Approval: 1988
Approved
Approval ID
a7af968c-05cf-4438-94ba-96a2baf9c367
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 7, 2022
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mesna Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-161
Application NumberANDA206992
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mesna Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 7, 2022
FDA Product Classification
INGREDIENTS (4)
BENZYL ALCOHOLInactive
Quantity: 1.04 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.25 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MESNAActive
Quantity: 100 mg in 1 mL
Code: NR7O1405Q9
Classification: ACTIB