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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208054

Marketing Status: Prescription
Active Ingredient: FLUCICLOVINE F-18
Proprietary Name: AXUMIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 9-221mCi/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208054
Product Number: 001
Approval Date: May 27, 2016
Applicant Holder Full Name: BLUE EARTH DIAGNOSTICS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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