← FDA DRUG APPROVALS

FDA NDA · NDA212018

BALVERSA

erdafitinib

Sponsor: JANSSEN BIOTECH

APPLICATION
NDA212018
TYPE
NDA
ORIGINAL APPROVAL
2019-04-12
LATEST ACTION
2025-10-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BALVERSA · ReferencePrescription
ERDAFITINIB 3MG · TABLET · ORAL
BALVERSA · ReferencePrescription
ERDAFITINIB 4MG · TABLET · ORAL
BALVERSA · ReferencePrescription
ERDAFITINIB 5MG · TABLET · ORAL

Approval history

2025-10-17Labeling · Supplement 11 · standard — Label ↗AP
2024-10-09Labeling · Supplement 10 · standard — Label ↗AP
2024-01-19Efficacy · Supplement 8 · priority — Label ↗AP
2024-01-19Efficacy · Supplement 9 · priority — Label ↗AP
2024-01-19Labeling · Supplement 7 · standard — Label ↗AP
2023-03-20Labeling · Supplement 5 · standard — Letter ↗AP
2023-01-11Labeling · Supplement 4 · standard — Letter ↗AP
2022-04-27Labeling · Supplement 3 · standard — Label ↗AP
2022-04-27Labeling · Supplement 2 · standard — Label ↗AP
2020-04-02Labeling · Supplement 1 · standard — Letter ↗AP
2019-04-12Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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