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FDA NDA · NDA220073

ELIQUIS

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APPLICATION
NDA220073
TYPE
NDA
ORIGINAL APPROVAL
2025-04-17
LATEST ACTION
2026-06-24
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

ELIQUISPrescription
APIXABAN 0.15MG · SUSPENSION · ORAL
ELIQUISPrescription
APIXABAN 5MG · TABLET · ORAL
ELIQUISPrescription
APIXABAN 0.5MG · TABLET · ORAL
ELIQUIS SPRINKLE · ReferencePrescription
APIXABAN 0.15MG · FOR SUSPENSION · ORAL

Approval history

2026-06-24Labeling · Supplement 1 · standard — Letter ↗AP
2025-04-17Type 3 - New Dosage Form · Original · priority — Label ↗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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