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General MedicationsINJECTIONStandard

HADLIMA

ADALIMUMAB-BWWD

Standard Dose
40MG/0.8ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview HADLIMA is listed in Drugs@FDA under application 761059 (BLA).

Review priority: N/A Marketing status: Prescription Active ingredient ADALIMUMAB-BWWD Form and strength INJECTABLE;INJECTION - 40MG/0.8ML Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2025-10-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview HADLIMA is listed in Drugs@FDA under application 761059 (BLA). Review priority: N/A Marketing status: Prescription Active ingredient ADALIMUMAB-BWWD Form and strength INJECTABLE;INJECTION - 40MG/0.8ML Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2025-10-17 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.