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FDA NDA · NDA215841

LOCAMETZ

kit for the preparation of gallium ga 68 gozetotide

Sponsor: NOVARTIS

APPLICATION
NDA215841
TYPE
NDA
ORIGINAL APPROVAL
2022-03-23
LATEST ACTION
2025-03-28
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

LOCAMETZ · ReferencePrescription
GALLIUM GA-68 GOZETOTIDE N/A · POWDER · INTRAVENOUS

Approval history

2025-03-28Labeling · Supplement 6 · standard — Label ↗AP
2022-03-23Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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