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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203811

FLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F-18)
4-40mCi/ML
Marketing Status: Prescription
Active Ingredient: FLUDEOXYGLUCOSE F-18
Proprietary Name: FLUDEOXYGLUCOSE F18
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 4-40mCi/ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A203811
Product Number: 001
Approval Date: Jun 27, 2013
Applicant Holder Full Name: UCLA BIOMEDICAL CYCLOTRON
Marketing Status:  Prescription
Patent and Exclusivity Information
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