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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216023

POSLUMA (FLOTUFOLASTAT F-18 GALLIUM)
25ML (8-158mCi/ML)
Marketing Status: Prescription
Active Ingredient: FLOTUFOLASTAT F-18 GALLIUM
Proprietary Name: POSLUMA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 25ML (8-158mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216023
Product Number: 001
Approval Date: May 25, 2023
Applicant Holder Full Name: BLUE EARTH DIAGNOSTICS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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