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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200655

FLUORODOPA F18 (FLUORODOPA F-18)
0.42-8.33mCi/ML
Marketing Status: Prescription
Active Ingredient: FLUORODOPA F-18
Proprietary Name: FLUORODOPA F18
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.42-8.33mCi/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N200655
Product Number: 001
Approval Date: Oct 10, 2019
Applicant Holder Full Name: FEINSTEIN INSTITUTE MEDICAL RESEARCH
Marketing Status:  Prescription
Patent and Exclusivity Information
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