Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211280
Company: ELI LILLY AND CO

• Medication Guide

Products on NDA 211280

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REYVOW	LASMIDITAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	None	Yes	No
REYVOW	LASMIDITAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
REYVOW	LASMIDITAN SUCCINATE	EQ 200MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211280

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
10/11/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – January 31, 2020

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
09/15/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)
07/15/2022	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)
01/25/2022	SUPPL-6	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.
06/03/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)
07/17/2020	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)

Labels for NDA 211280

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
09/15/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)
07/15/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)
07/15/2022	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)
06/03/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)
07/17/2020	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)
07/17/2020	SUPPL-1	Labeling-Medication Guide	Label (PDF)
07/17/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)
10/11/2019	ORIG-1	Approval	Label (PDF)