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FDA BLA · BLA761067

ILUMYA

tildrakizumab-asmn

Sponsor: SUN PHARMA GLOBAL

APPLICATION
BLA761067
TYPE
BLA
ORIGINAL APPROVAL
2018-03-20
LATEST ACTION
2026-07-16
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ILUMYAPrescription
TILDRAKIZUMAB-ASMN 100MG/1ML · INJECTABLE · INJECTION

Approval history

2026-07-16Efficacy · Supplement 27 · standard — Letter ↗AP
2025-12-12Efficacy · Supplement 24 · standard — Letter ↗AP
2024-04-03Efficacy · Supplement 18 · standard — Letter ↗AP
2022-12-19Efficacy · Supplement 14 · standard — Label ↗AP
2018-03-20Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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