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General MedicationsORALStandard

DROSPIRENONE AND ESTRADIOL

DROSPIRENONE; ESTRADIOL

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

Approval overview DROSPIRENONE AND ESTRADIOL is listed in Drugs@FDA under application 218031 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ESTRADIOL Form and strength TABLET;ORAL - 0.5MG;1MG Sponsor NOVAST LABS Submission history Latest submission status date: 2025-10-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview DROSPIRENONE AND ESTRADIOL is listed in Drugs@FDA under application 218031 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ESTRADIOL Form and strength TABLET;ORAL - 0.5MG;1MG Sponsor NOVAST LABS Submission history Latest submission status date: 2025-10-28 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
DROSPIRENONE AND ESTRADIOL (DROSPIRENONE; ESTRADIOL) | Drug Monograph | MedicHelpline