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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213227

4mL (1mCi/ML)
Marketing Status: Prescription
Active Ingredient: COPPER DOTATATE CU-64
Proprietary Name: DETECTNET
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 4mL (1mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213227
Product Number: 001
Approval Date: Sep 3, 2020
Applicant Holder Full Name: RADIOMEDIX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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