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FDA BLA · BLA761145

DARZALEX FASPRO

daratumumab and hyaluronidase-fihj (human recombinant)

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761145
TYPE
BLA
ORIGINAL APPROVAL
2020-05-01
LATEST ACTION
2026-02-12
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DARZALEX FASPROPrescription
DARATUMUMAB AND HYALURONIDASE-FIHJ 120MG · INJECTABLE · INJECTION

Approval history

2026-02-12Labeling · Supplement 39 · standard — Letter ↗AP
2026-01-27Efficacy · Supplement 28 · standard — Letter ↗AP
2025-11-19Efficacy · Supplement 32 · standard — Label ↗AP
2025-11-14Labeling · Supplement 35 · standard — Label ↗AP
2025-11-06Efficacy · Supplement 29 · standard — Letter ↗AP
2024-07-30Efficacy · Supplement 25 · priority — Label ↗AP
2022-11-02Labeling · Supplement 18 · standard — Letter ↗AP
2022-01-21Labeling · Supplement 12 · standard — Letter ↗AP
2021-11-30Efficacy · Supplement 9 · standard — Label ↗AP
2021-07-09Efficacy · Supplement 7 · standard — Label ↗AP
2021-03-12Labeling · Supplement 5 · standard — Label ↗AP
2021-02-08Labeling · Supplement 8 · standard — Letter ↗AP
2021-01-15Efficacy · Supplement 2 · priority — Label ↗AP
2021-01-11Efficacy · Supplement 1 · standard — Label ↗AP
2020-05-01Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Label ↗AP
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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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