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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203246

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FLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F-18)
20-300mCi/ML
Marketing Status: Prescription
Active Ingredient: FLUDEOXYGLUCOSE F-18
Proprietary Name: FLUDEOXYGLUCOSE F18
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 20-300mCi/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203246
Product Number: 002
Approval Date: Jan 13, 2014
Applicant Holder Full Name: UNIV TEXAS MD ANDERSON CANCER CENTER
Marketing Status:  Prescription
Patent and Exclusivity Information
FLUDEOXYGLUCOSE F18 (FLUDEOXYGLUCOSE F-18)
20-150mCi/ML
Marketing Status: Prescription
Active Ingredient: FLUDEOXYGLUCOSE F-18
Proprietary Name: FLUDEOXYGLUCOSE F18
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 20-150mCi/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203246
Product Number: 001
Approval Date: Jan 13, 2014
Applicant Holder Full Name: UNIV TEXAS MD ANDERSON CANCER CENTER
Marketing Status:  Prescription
Patent and Exclusivity Information
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