Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216951
Company: GLAXOSMITHKLINE

• Medication Guide

Products on NDA 216951

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JESDUVROQ	DAPRODUSTAT	1MG	TABLET;ORAL	Discontinued	None	Yes	No
JESDUVROQ	DAPRODUSTAT	2MG	TABLET;ORAL	Discontinued	None	Yes	No
JESDUVROQ	DAPRODUSTAT	4MG	TABLET;ORAL	Discontinued	None	Yes	No
JESDUVROQ	DAPRODUSTAT	6MG	TABLET;ORAL	Discontinued	None	Yes	No
JESDUVROQ	DAPRODUSTAT	8MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216951

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216951s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216951Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216951Orig1s000TOC.cfm

Labels for NDA 216951

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216951s000lbl.pdf