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FDA Approval

Fludeoxyglucose F18

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
DUNS: 110565913
Effective Date
January 18, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fludeoxyglucose (18F)(300 mCi in 1 mL)

Products1

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

Fludeoxyglucose F18

Product Details

NDC Product Code
13267-123
Application Number
NDA021870
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
January 18, 2012
Code: 0Z5B2CJX4DClass: ACTIBQuantity: 300 mCi in 1 mL
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