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General MedicationsORALStandard

FEMLYV

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Standard Dose
0.02MG;1MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview FEMLYV is listed in Drugs@FDA under application 218718 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 0.02MG;1MG Sponsor MILLICENT PR Submission history Latest submission status date: 2025-07-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview FEMLYV is listed in Drugs@FDA under application 218718 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 0.02MG;1MG Sponsor MILLICENT PR Submission history Latest submission status date: 2025-07-29 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.