← FDA DRUG APPROVALS

FDA NDA · NDA217673

BRINSUPRI

brensocatib

Sponsor: INSMED INC

APPLICATION
NDA217673
TYPE
NDA
ORIGINAL APPROVAL
2025-08-12
LATEST ACTION
2025-08-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BRINSUPRI · ReferencePrescription
BRENSOCATIB 25MG · TABLET · ORAL
BRINSUPRI · ReferencePrescription
BRENSOCATIB 10MG · TABLET · ORAL

Approval history

2025-08-12Type 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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