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Fludeoxyglucose F-18

Approved
Approval ID

0eb82924-1ce4-680e-e054-00144ff88e88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 10, 2015

Manufacturers
FDA

University of North Dakota

DUNS: 031637015

Products 1

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

Fludeoxyglucose F-18 Injection

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24468-001
Application NumberANDA203994
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fludeoxyglucose F-18 Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 10, 2015
FDA Product Classification

INGREDIENTS (1)

Fludeoxyglucose F-18Active
Quantity: 500 mCi in 1 mL
Code: 0Z5B2CJX4D
Classification: ACTIB

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Fludeoxyglucose F-18 - FDA Drug Approval Details