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General MedicationsIV (INFUSION)Standard

DATROWAY

DATOPOTAMAB DERUXTECAN-DLNK

Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DATROWAY is listed in Drugs@FDA under application 761394 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DATOPOTAMAB DERUXTECAN-DLNK Form and strength INJECTABLE; IV (INFUSION) - 100MG Sponsor DAIICHI SANKYO INC Submission history Latest submission status date: 2025-01-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview DATROWAY is listed in Drugs@FDA under application 761394 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient DATOPOTAMAB DERUXTECAN-DLNK Form and strength INJECTABLE; IV (INFUSION) - 100MG Sponsor DAIICHI SANKYO INC Submission history Latest submission status date: 2025-01-17 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.