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General MedicationsIV (INFUSION)Standard

ONTRUZANT

TRASTUZUMAB-DTTB

Standard Dose
420MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ONTRUZANT is listed in Drugs@FDA under application 761100 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TRASTUZUMAB-DTTB Form and strength POWDER;IV (INFUSION) - 420MG Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2025-12-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview ONTRUZANT is listed in Drugs@FDA under application 761100 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient TRASTUZUMAB-DTTB Form and strength POWDER;IV (INFUSION) - 420MG Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2025-12-05 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.