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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216834
Company: UCB INC

Medication Guide

Products on NDA 216834

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZILBRYSQ	ZILUCOPLAN SODIUM	EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
ZILBRYSQ	ZILUCOPLAN SODIUM	EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
ZILBRYSQ	ZILUCOPLAN SODIUM	EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216834

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216834s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216834Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216834Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2024	SUPPL-4	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216834Orig1s004ltr.pdf
04/26/2024	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216834s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216834Orig1s001ltr.pdf

Labels for NDA 216834

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2024	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216834s001lbl.pdf
10/17/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216834s000lbl.pdf

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