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General MedicationsINJECTIONStandard

ENJAYMO

SUTIMLIMAB-JOME

Standard Dose
1,100MG/22ML(50MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ENJAYMO is listed in Drugs@FDA under application 761164 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SUTIMLIMAB-JOME Form and strength INJECTABLE;INJECTION - 1,100MG/22ML(50MG/ML) Sponsor RECORDATI RARE DISEASES, INC.

Structured Monograph

Clinical summary

Approval overview ENJAYMO is listed in Drugs@FDA under application 761164 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient SUTIMLIMAB-JOME Form and strength INJECTABLE;INJECTION - 1,100MG/22ML(50MG/ML) Sponsor RECORDATI RARE DISEASES, INC. Submission history Latest submission status date: 2024-02-08 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.