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