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FDA NDA · NDA211765

UBRELVY

ubrogepant

Sponsor: ABBVIE

APPLICATION
NDA211765
TYPE
NDA
ORIGINAL APPROVAL
2019-12-23
LATEST ACTION
2025-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

UBRELVY · ReferencePrescription
UBROGEPANT 50MG · TABLET · ORAL
UBRELVY · ReferencePrescription
UBROGEPANT 100MG · TABLET · ORAL

Approval history

2025-06-05Labeling · Supplement 12 · standard — Letter ↗AP
2025-03-21Labeling · Supplement 13 · standard — Label ↗AP
2023-02-17Labeling · Supplement 7 · standard — Letter ↗AP
2021-03-03Labeling · Supplement 2 · standard — Letter ↗AP
2019-12-23Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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