← FDA DRUG APPROVALS

FDA NDA · NDA215341

KERENDIA

finerenone

Sponsor: BAYER HLTHCARE

APPLICATION
NDA215341
TYPE
NDA
ORIGINAL APPROVAL
2021-07-09
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

KERENDIA · ReferencePrescription
FINERENONE 20MG · TABLET · ORAL
KERENDIA · ReferencePrescription
FINERENONE 40MG · TABLET · ORAL
KERENDIA · ReferencePrescription
FINERENONE 10MG · TABLET · ORAL

Approval history

2025-07-11Efficacy · Supplement 9 · priority — Label ↗AP
2022-09-01Efficacy · Supplement 1 · standard — Letter ↗AP
2021-07-09Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →