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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210828

GALLIUM GA 68 EDOTREOTIDE (GALLIUM GA-68 EDOTREOTIDE)
0.5-4mCi/ML
Marketing Status: Prescription
Active Ingredient: GALLIUM GA-68 EDOTREOTIDE
Proprietary Name: GALLIUM GA 68 EDOTREOTIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.5-4mCi/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210828
Product Number: 001
Approval Date: Aug 21, 2019
Applicant Holder Full Name: UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER
Marketing Status:  Prescription
Patent and Exclusivity Information
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