Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216403
Company: TRAVERE

• Medication Guide

• REMS

Products on NDA 216403

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FILSPARI	SPARSENTAN	200MG	TABLET;ORAL	Prescription	None	Yes	No
FILSPARI	SPARSENTAN	400MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216403

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216403s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216403Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216403Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2024	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216403s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216403Orig1s003ltr.pdf
10/18/2023	SUPPL-2	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216403Orig1s002ltr.pdf

Labels for NDA 216403

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2024	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216403s003lbl.pdf
02/17/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216403s000lbl.pdf