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General MedicationsINJECTIONStandard

RYBREVANT FASPRO

AMIVANTAMAB AND HYALURONIDASE-LPUJ

Standard Dose
10ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview RYBREVANT FASPRO is listed in Drugs@FDA under application 761433 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient AMIVANTAMAB AND HYALURONIDASE-LPUJ Form and strength INJECTION - 10ML Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-12-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview RYBREVANT FASPRO is listed in Drugs@FDA under application 761433 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient AMIVANTAMAB AND HYALURONIDASE-LPUJ Form and strength INJECTION - 10ML Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-12-17 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.