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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214032
Company: TELIX

Products on NDA 214032

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ILLUCCIX	GALLIUM GA-68 GOZETOTIDE	N/A	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214032

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2021	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214032Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214032Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2025	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214032s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214032Orig1s018ltr.pdf
09/11/2025	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214032s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214032Orig1s014ltr.pdf
03/15/2023	SUPPL-1	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214032s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214032Orig1s001ltr.pdf

Labels for NDA 214032

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2025	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214032s018lbl.pdf
09/11/2025	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214032s014lbl.pdf
03/15/2023	SUPPL-1	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214032s001lbl.pdf

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