Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215842
Company: NOVO

Products on NDA 215842

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIVFLOZA	NEDOSIRAN SODIUM	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION;INJECTION	Prescription	None	Yes	Yes
RIVFLOZA	NEDOSIRAN SODIUM	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION;INJECTION	Prescription	None	Yes	Yes
RIVFLOZA	NEDOSIRAN SODIUM	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215842

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215842s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215842Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215842Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2025	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215842s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215842Orig1s002ltr.pdf

Labels for NDA 215842

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2025	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215842s002lbl.pdf
09/29/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215842s000lbl.pdf