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EVOMELA

These highlights do not include all the information needed to use EVOMELA safely and effectively. See full prescribing information for EVOMELA. EVOMELA (melphalan) for injection, for intravenous use. Initial U.S. Approval: 1964

Approved
Approval ID

69f55869-dc11-408e-8fc7-47634269a52c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 13, 2023

Manufacturers
FDA

Acrotech Biopharma Inc

DUNS: 116965616

Products 1

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

Melphalan

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72893-001
Application NumberNDA207155
Product Classification
M
Marketing Category
C73594
G
Generic Name
Melphalan
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2023
FDA Product Classification

INGREDIENTS (2)

MELPHALAN HYDROCHLORIDEActive
Quantity: 50 mg in 10 mL
Code: 1VXP4V453T
Classification: ACTIM
BETADEX SULFOBUTYL ETHER SODIUMInactive
Quantity: 2700 mg in 10 mL
Code: 2PP9364507
Classification: IACT

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