Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsINJECTIONStandard

SIMLANDI

ADALIMUMAB-RYVK

Standard Dose
40MG/0.4ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SIMLANDI is listed in Drugs@FDA under application 761299 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ADALIMUMAB-RYVK Form and strength INJECTABLE;INJECTION - 40MG/0.4ML Sponsor ALVOTECH USA INC Submission history Latest submission status date: 2025-11-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview SIMLANDI is listed in Drugs@FDA under application 761299 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ADALIMUMAB-RYVK Form and strength INJECTABLE;INJECTION - 40MG/0.4ML Sponsor ALVOTECH USA INC Submission history Latest submission status date: 2025-11-06 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.