General MedicationsINJECTIONStandard
TECVAYLI
TECLISTAMAB-CQYV
Standard Dose
30MG/3ML(10MG/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 - 30MG/3ML(10MG/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 - 30MG/3ML(10MG/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.