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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208700

LUTATHERA (LUTETIUM LU 177 DOTATATE)
10mCi/ML
Marketing Status: Prescription
Active Ingredient: LUTETIUM LU 177 DOTATATE
Proprietary Name: LUTATHERA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10mCi/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208700
Product Number: 001
Approval Date: Jan 26, 2018
Applicant Holder Full Name: ADVANCED ACCELERATOR APPLICATIONS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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