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General MedicationsORALStandard

NEXTSTELLIS

DROSPIRENONE; ESTETROL

Standard Dose
3MG;14.2MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NEXTSTELLIS is listed in Drugs@FDA under application 214154 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ESTETROL Form and strength TABLET;ORAL - 3MG;14.2MG Sponsor MAYNE PHARMA Submission history Latest submission status date: 2022-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview NEXTSTELLIS is listed in Drugs@FDA under application 214154 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ESTETROL Form and strength TABLET;ORAL - 3MG;14.2MG 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.