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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209884
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAYZENT SIPONIMOD FUMARIC ACID EQ 0.25MG BASE TABLET;ORAL Prescription None Yes No
MAYZENT SIPONIMOD FUMARIC ACID EQ 2MG BASE TABLET;ORAL Prescription None Yes Yes
MAYZENT SIPONIMOD FUMARIC ACID EQ 1MG BASE TABLET;ORAL Prescription None Yes No
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
06/21/2022 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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