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FDA NDA · NDA211280

REYVOW

lasmiditan

Sponsor: ELI LILLY AND CO

APPLICATION
NDA211280
TYPE
NDA
ORIGINAL APPROVAL
2019-10-11
LATEST ACTION
2022-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

REYVOW · ReferenceDiscontinued
LASMIDITAN SUCCINATE EQ 100MG BASE · TABLET · ORAL
REYVOW · ReferenceDiscontinued
LASMIDITAN SUCCINATE EQ 200MG BASE · TABLET · ORAL
REYVOW · ReferenceDiscontinued
LASMIDITAN SUCCINATE EQ 50MG BASE · TABLET · ORAL

Approval history

2022-09-15Labeling · Supplement 8 · standard — Letter ↗AP
2022-07-15Labeling · Supplement 7 · standard — Letter ↗AP
2022-01-25Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2021-06-03Labeling · Supplement 5 · standard — Label ↗AP
2020-07-17Labeling · Supplement 1 · standard — Letter ↗AP
2019-10-11Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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