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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208547

NETSPOT (GALLIUM DOTATATE GA-68)
2.1-5.5mCi/ML
Marketing Status: Prescription
Active Ingredient: GALLIUM DOTATATE GA-68
Proprietary Name: NETSPOT
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 2.1-5.5mCi/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208547
Product Number: 001
Approval Date: Jun 1, 2016
Applicant Holder Full Name: ADVANCED ACCELERATOR APPLICATIONS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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