← FDA DRUG APPROVALS

FDA NDA · NDA214032

ILLUCCIX

kit for the preparation of gallium ga 68 gozetotide injection

Sponsor: TELIX

APPLICATION
NDA214032
TYPE
NDA
ORIGINAL APPROVAL
2021-12-17
LATEST ACTION
2025-12-05
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

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

Approval history

2025-12-05Labeling · Supplement 18 · standard — Letter ↗AP
2025-09-11Labeling · Supplement 14 · standard — Letter ↗AP
2023-03-15Efficacy · Supplement 1 · standard — Label ↗AP
2021-12-17Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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