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General MedicationsINJECTIONStandard

RYBREVANT

AMIVANTAMAB-VMJW

Standard Dose
350MG/7ML(50MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview RYBREVANT is listed in Drugs@FDA under application 761210 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMIVANTAMAB-VMJW Form and strength INJECTABLE;INJECTION - 350MG/7ML(50MG/ML) Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-11-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview RYBREVANT is listed in Drugs@FDA under application 761210 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMIVANTAMAB-VMJW Form and strength INJECTABLE;INJECTION - 350MG/7ML(50MG/ML) Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-11-07 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.