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FDA BLA · BLA761036

DARZALEX

daratumumab

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761036
TYPE
BLA
ORIGINAL APPROVAL
2015-11-16
LATEST ACTION
2026-05-28
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DARZALEXPrescription
DARATUMUMAB 400MG/20ML · INJECTABLE · INJECTION
DARZALEXPrescription
DARATUMUMAB 100MG/5ML · INJECTABLE · INJECTION

Approval history

2026-05-28Labeling · Supplement 61 · standard — Label ↗AP
2025-04-10Efficacy · Supplement 54 · standard — Letter ↗AP
2025-01-23Efficacy · Supplement 51 · standard — Label ↗AP
2024-07-31Efficacy · Supplement 50 · standard — Letter ↗AP
2023-01-19Efficacy · Supplement 44 · standard — Label ↗AP
2022-11-01Labeling · Supplement 45 · standard — Letter ↗AP
2022-03-04Efficacy · Supplement 41 · standard — Letter ↗AP
2022-01-21Labeling · Supplement 40 · standard — Letter ↗AP
2021-07-09Labeling · Supplement 35 · standard — Letter ↗AP
2021-03-12Labeling · Supplement 33 · standard — Label ↗AP
2020-08-20Efficacy · Supplement 29 · standard — Label ↗AP
2020-06-29Efficacy · Supplement 26 · standard — Label ↗AP
2020-04-17Labeling · Supplement 27 · standard — Letter ↗AP
2019-09-26Efficacy · Supplement 24 · priority — Label ↗AP
2019-07-16Labeling · Supplement 19 · standard — Label ↗AP
2019-06-27Efficacy · Supplement 20 · priority — Label ↗AP
2019-02-08Efficacy · Supplement 16 · standard — Label ↗AP
2018-06-18Labeling · Supplement 14 · standard — Letter ↗AP
2018-05-07Efficacy · Supplement 13 · priority — Letter ↗AP
2017-06-16Efficacy · Supplement 5 · standard — Label ↗AP
2016-11-21Efficacy · Supplement 4 · priority — Label ↗AP
2016-11-21Efficacy · Supplement 3 · priority — Letter ↗AP
2015-11-16Type 1 - New Molecular Entity · Original · priority — Review ↗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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