← FDA DRUG APPROVALS

FDA NDA · NDA215110

MAVYRET

glecaprevir and pibrentasvir

Sponsor: ABBVIE

APPLICATION
NDA215110
TYPE
NDA
ORIGINAL APPROVAL
2021-06-10
LATEST ACTION
2025-06-10
ROUTE
ORAL
DOSAGE FORM
PELLETS
MARKETING STATUS
Prescription

Products

MAVYRET · ReferencePrescription
GLECAPREVIR 50MG/PACKET, PIBRENTASVIR 20MG/PACKET · PELLETS · ORAL

Approval history

2025-06-10Efficacy · Supplement 5 · priority — Label ↗AP
2023-10-25Labeling · Supplement 3 · standard — Letter ↗AP
2021-09-28Labeling · Supplement 1 · standard — Letter ↗AP
2021-06-10Type 3 - New Dosage Form · 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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