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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209401
Company: JAZZ PHARMS THERAP

Products on NDA 209401

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VYXEOS	CYTARABINE; DAUNORUBICIN	100MG;44MG	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209401

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2017	ORIG-1	Approval	Type 4 - New Combination	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209401Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209401Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2026	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209401s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/209401Orig1s018ltr.pdf
09/27/2022	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209401s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209401Orig1s011ltr.pdf
03/30/2021	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209401s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209401Orig1s006ltr.pdf
01/13/2020	SUPPL-2	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209401Orig1s002ltr.pdf

Labels for NDA 209401

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2026	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209401s018lbl.pdf
09/27/2022	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209401s011lbl.pdf
03/30/2021	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209401s006lbl.pdf
08/03/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf

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