General MedicationsINJECTIONStandard
ENHERTU
FAM-TRASTUZUMAB DERUXTECAN-NXKI
Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ENHERTU is listed in Drugs@FDA under application 761139 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FAM-TRASTUZUMAB DERUXTECAN-NXKI Form and strength INJECTABLE;INJECTION - 100MG Sponsor DAIICHI SANKYO Submission history Latest submission status date: 2025-12-15 00:00:00.
Structured Monograph
Clinical summary
Approval overview ENHERTU is listed in Drugs@FDA under application 761139 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient FAM-TRASTUZUMAB DERUXTECAN-NXKI Form and strength INJECTABLE;INJECTION - 100MG Sponsor DAIICHI SANKYO Submission history Latest submission status date: 2025-12-15 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.