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General MedicationsINJECTIONStandard

TECVAYLI

TECLISTAMAB-CQYV

Standard Dose
153MG/1.7ML(90MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview TECVAYLI is listed in Drugs@FDA under application 761291 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient TECLISTAMAB-CQYV Form and strength INJECTABLE;INJECTION - 153MG/1.7ML(90MG/ML) Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2026-03-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview TECVAYLI is listed in Drugs@FDA under application 761291 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient TECLISTAMAB-CQYV Form and strength INJECTABLE;INJECTION - 153MG/1.7ML(90MG/ML) Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2026-03-05 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.