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General MedicationsINJECTIONStandard

INFLECTRA

INFLIXIMAB-DYYB

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

Approval overview INFLECTRA is listed in Drugs@FDA under application 125544 (BLA).

Marketing status: Prescription Active ingredient INFLIXIMAB-DYYB Form and strength INJECTABLE;INJECTION - 100MG Sponsor CELLTRION INC Submission history Latest submission status date: 2025-09-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview INFLECTRA is listed in Drugs@FDA under application 125544 (BLA). Marketing status: Prescription Active ingredient INFLIXIMAB-DYYB Form and strength INJECTABLE;INJECTION - 100MG Sponsor CELLTRION INC Submission history Latest submission status date: 2025-09-03 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription

Interaction Notes

  • No interaction notes stored yet.