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General MedicationsORALStandard

MYFEMBREE

ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Standard Dose
1MG;0.5MG;40MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MYFEMBREE is listed in Drugs@FDA under application 214846 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX Form and strength TABLET;ORAL - 1MG;0.5MG;40MG Sponsor SUMITOMO PHARMA AM Submission history Latest submission status date: 2025-08-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview MYFEMBREE is listed in Drugs@FDA under application 214846 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX Form and strength TABLET;ORAL - 1MG;0.5MG;40MG Sponsor SUMITOMO PHARMA AM Submission history Latest submission status date: 2025-08-27 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.