General MedicationsVAGINALStandard

ANNOVERA

ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Standard Dose

0.013MG/24HR;0.15MG/24HR

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ANNOVERA is listed in Drugs@FDA under application 209627 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; SEGESTERONE ACETATE Form and strength RING;VAGINAL - 0.013MG/24HR;0.15MG/24HR Sponsor MAYNE PHARMA Submission history Latest submission status date: 2022-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview ANNOVERA is listed in Drugs@FDA under application 209627 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; SEGESTERONE ACETATE Form and strength RING;VAGINAL - 0.013MG/24HR;0.15MG/24HR Sponsor MAYNE PHARMA Submission history Latest submission status date: 2022-04-29 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.