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Janssen Biotech FDA Approvals

10 new drug approvals and 0 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
ICOTYDENew drugMar 17, 2026TABLET, ORAL
RYBREVANT FASPRONew drugFeb 13, 2026VIAL, SINGLE-USE
RYBREVANT FASPRONew drugDec 17, 2025INJECTION
INLEXZONew drugSep 9, 2025SYSTEM, INTRAVESICAL
IMAAVYNew drugApr 29, 2025INJECTABLE, INJECTION
LAZCLUZENew drugAug 19, 2024TABLET, ORAL
AKEEGANew drugAug 11, 2023TABLET, ORAL
TALVEYNew drugAug 9, 2023INJECTABLE, INJECTION
TECVAYLINew drugOct 25, 2022INJECTABLE, INJECTION
RYBREVANTNew drugMay 21, 2021INJECTABLE, INJECTION

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