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General MedicationsINJECTIONStandard

OTULFI

USTEKINUMAB-AAUZ

Standard Dose
130MG/26ML
Max Dose
Refer to approved labeling
Primary Use
Marketing status: Prescription
Summary

Approval overview OTULFI is listed in Drugs@FDA under application 761379 (BLA).

Marketing status: Prescription Active ingredient USTEKINUMAB-AAUZ Form and strength INJECTABLE;INJECTION - 130MG/26ML Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2026-01-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview OTULFI is listed in Drugs@FDA under application 761379 (BLA). Marketing status: Prescription Active ingredient USTEKINUMAB-AAUZ Form and strength INJECTABLE;INJECTION - 130MG/26ML Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2026-01-15 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription

Interaction Notes

  • No interaction notes stored yet.