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General MedicationsINJECTIONStandard

DARZALEX FASPRO

DARATUMUMAB AND HYALURONIDASE-FIHJ

Standard Dose
120MG;2000UNITS/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DARZALEX FASPRO is listed in Drugs@FDA under application 761145 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DARATUMUMAB AND HYALURONIDASE-FIHJ Form and strength INJECTABLE;INJECTION - 120MG;2000UNITS/ML Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2026-02-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview DARZALEX FASPRO is listed in Drugs@FDA under application 761145 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient DARATUMUMAB AND HYALURONIDASE-FIHJ Form and strength INJECTABLE;INJECTION - 120MG;2000UNITS/ML Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2026-02-12 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.