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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214962
Company: CYCLE

Medication Guide

Products on NDA 214962

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TASCENSO ODT	FINGOLIMOD LAURYL SULFATE	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	None	Yes	No
TASCENSO ODT	FINGOLIMOD LAURYL SULFATE	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214962

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2021	ORIG-2	Approval		STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214962Orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214962Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214962Orig2s000TOC.cfm
12/09/2022	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214962s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214962Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/28/2025	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214962s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214962Orig1s003ltr.pdf
06/05/2024	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214962s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214962Orig1s002ltr.pdf
08/10/2023	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214962s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214962Orig1s001ltr.pdf

Labels for NDA 214962

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/28/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214962s003lbl.pdf
01/28/2025	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214962s003lbl.pdf
01/28/2025	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214962s003lbl.pdf
06/05/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214962s002lbl.pdf
06/05/2024	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214962s002lbl.pdf
08/10/2023	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214962s001lbl.pdf
12/09/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214962s000lbl.pdf
12/23/2021	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214962Orig2lbl.pdf

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