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FDA NDA · NDA218764

JASCAYD

nerandomilast

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA218764
TYPE
NDA
ORIGINAL APPROVAL
2025-10-07
LATEST ACTION
2026-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JASCAYD · ReferencePrescription
NERANDOMILAST 18MG · TABLET · ORAL
JASCAYD · ReferencePrescription
NERANDOMILAST 9MG · TABLET · ORAL

Approval history

2026-02-26Labeling · Supplement 1 · standard — Label ↗AP
2025-10-07Type 1 - New Molecular Entity · 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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