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General MedicationsSUBCUTANEOUSStandard

ENBREL

ETANERCEPT

Standard Dose
25MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ENBREL is listed in Drugs@FDA under application 103795 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETANERCEPT Form and strength VIAL; SUBCUTANEOUS - 25MG/VIAL Sponsor IMMUNEX Submission history Latest submission status date: 2026-01-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview ENBREL is listed in Drugs@FDA under application 103795 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETANERCEPT Form and strength VIAL; SUBCUTANEOUS - 25MG/VIAL Sponsor IMMUNEX Submission history Latest submission status date: 2026-01-30 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.