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Ifosfamide

These highlights do not include all the information needed to use IFOSFAMIDE FOR INJECTION safely and effectively.  See full prescribing information for IFOSFAMIDE FOR INJECTION.IFOSFAMIDE for injection, intravenous useInitial U.S. Approval: 1988

Approved
Approval ID

a311a947-7b78-4226-bfe0-f4aa0be20e27

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 22, 2017

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

Products 1

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

IFOSFAMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-142
Application NumberANDA076078
Product Classification
M
Marketing Category
C73584
G
Generic Name
IFOSFAMIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2017
FDA Product Classification

INGREDIENTS (2)

IFOSFAMIDEActive
Quantity: 1 g in 1 1
Code: UM20QQM95Y
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT

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Ifosfamide - FDA Drug Approval Details