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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209884
Company: NOVARTIS

Medication Guide

Products on NDA 209884

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAYZENT	SIPONIMOD	EQ 0.25MG BASE	TABLET;ORAL	Prescription	None	Yes	No
MAYZENT	SIPONIMOD	EQ 2MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
MAYZENT	SIPONIMOD	EQ 1MG BASE	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209884

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209884s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209884Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209884Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209884s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209884Orig1s019ltr.pdf
08/10/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209884s016s018lbl.pdf
08/10/2023	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209884s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209884Orig1s016,s018ltr.pdf
01/31/2023	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209884s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209884Orig1s015ltr.pdf
06/21/2022	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209884Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209884Orig1s011ltr.pdf
06/10/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209884s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209884Orig1s010ltr.pdf
03/01/2022	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209884s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209884Orig1s007ltr.pdf
08/24/2021	SUPPL-6		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209884Orig1s006Lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209884Orig1s006CorrectedLtr.pdf
09/10/2021	SUPPL-5	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209884Orig1s005ltr.pdf
01/23/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209884s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209884Orig1s003ltr.pdf
07/31/2020	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209884s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209884Orig1s002ltr.pdf

Labels for NDA 209884

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209884s019lbl.pdf
08/10/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209884s016s018lbl.pdf
08/10/2023	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209884s016s018lbl.pdf
08/10/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209884s016s018lbl.pdf
01/31/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209884s015lbl.pdf
06/21/2022	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209884Orig1s011lbl.pdf
06/10/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209884s010lbl.pdf
03/01/2022	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209884s007lbl.pdf
08/24/2021	SUPPL-6	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209884Orig1s006Lbledt.pdf
01/23/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209884s003lbl.pdf
07/31/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209884s002lbl.pdf
07/31/2020	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209884s002lbl.pdf
03/26/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209884s000lbl.pdf

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