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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211349
Company: ASTELLAS

Medication Guide

Products on NDA 211349

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XOSPATA	GILTERITINIB FUMARATE	EQ 40MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211349s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211349Orig1s000replacementltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211349Orig1_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2022	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211349s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211349Orig1s003ltr.pdf
05/29/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211349s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211349Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211349Orig1s001.pdf

Labels for NDA 211349

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2022	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211349s003lbl.pdf
01/12/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211349s003lbl.pdf
05/29/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211349s001lbl.pdf
11/28/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211349s000lbl.pdf

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