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MESNEX

These highlights do not include all the information needed to use MESNEX safely and effectively. See full prescribing information for MESNEX. MESNEX (mesna) tablets, for oral use MESNEX (mesna) injection, for intravenous useInitial U.S. Approval: 1988

Approved
Approval ID

49fdfbc3-69f8-4706-9d11-bf60e4e7811b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 17, 2018

Manufacturers
FDA

Baxter Healthcare Corporation

DUNS: 005083209

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

mesna

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-1305
Application NumberNDA019884
Product Classification
M
Marketing Category
C73594
G
Generic Name
mesna
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 17, 2014
FDA Product Classification

INGREDIENTS (4)

MESNAActive
Quantity: 100 mg in 1 mL
Code: NR7O1405Q9
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 0.25 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 1.04 mg in 1 mL
Code: LKG8494WBH
Classification: IACT

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MESNEX - FDA Drug Approval Details