← FDA DRUG APPROVALS

FDA NDA · NDA215206

QULIPTA

atogepant

Sponsor: ABBVIE

APPLICATION
NDA215206
TYPE
NDA
ORIGINAL APPROVAL
2021-09-28
LATEST ACTION
2025-09-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

QULIPTA · ReferencePrescription
ATOGEPANT 30MG · TABLET · ORAL
QULIPTA · ReferencePrescription
ATOGEPANT 60MG · TABLET · ORAL
QULIPTA · ReferencePrescription
ATOGEPANT 10MG · TABLET · ORAL

Approval history

2025-09-30Labeling · Supplement 13 · standard — Label ↗AP
2025-06-10Labeling · Supplement 10 · standard — Letter ↗AP
2025-06-10Labeling · Supplement 12 · standard — Label ↗AP
2025-03-21Labeling · Supplement 11 · standard — Label ↗AP
2023-04-17Efficacy · Supplement 4 · standard — Label ↗AP
2021-09-28Type 1 - New Molecular Entity · Original · priority — 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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