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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215833
Company: NOVARTIS

Products on NDA 215833

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PLUVICTO	LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN	27mCi/ML	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215833

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2022	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215833s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215833Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215833Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2025	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215833s021,024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215833Orig1s021, s024ltr.pdf
03/28/2025	SUPPL-21	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215833s021,024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215833Orig1s021, s024ltr.pdf

Labels for NDA 215833

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2025	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215833s021,024lbl.pdf
03/28/2025	SUPPL-21	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215833s021,024lbl.pdf
03/23/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215833s000lbl.pdf

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