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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 219592

GOZELLIX (GALLIUM GA-68 GOZETOTIDE)
N/A
Marketing Status: Prescription
Active Ingredient: GALLIUM GA-68 GOZETOTIDE
Proprietary Name: GOZELLIX
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: N/A
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N219592
Product Number: 001
Approval Date: Mar 20, 2025
Applicant Holder Full Name: TELIX INNOVATIONS SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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