Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209607

AZEDRA (IOBENGUANE I-131)
15mCi/ML Marketing Status: Prescription

Active Ingredient: IOBENGUANE I-131
Proprietary Name: AZEDRA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 15mCi/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209607
Product Number: 001
Approval Date: Jul 30, 2018
Applicant Holder Full Name: PROGENICS PHARMACEUTICALS INC
Marketing Status:  Prescription
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