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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211280
Company: ELI LILLY AND CO
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
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-Patient Package Insert, Labeling-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-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
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-Patient Package Insert Label (PDF)
07/15/2022 SUPPL-7 Labeling-Package Insert Label (PDF)
06/03/2021 SUPPL-5 Labeling-Package Insert Label (PDF)
07/17/2020 SUPPL-1 Labeling-Medication Guide Label (PDF)
07/17/2020 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
07/17/2020 SUPPL-1 Labeling-Package Insert Label (PDF)
10/11/2019 ORIG-1 Approval Label (PDF)
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