Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORAL-28Standard

DROSPIRENONE AND ETHINYL ESTRADIOL

DROSPIRENONE; ETHINYL ESTRADIOL

Standard Dose
3MG;0.03MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DROSPIRENONE AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 213034 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ETHINYL ESTRADIOL Form and strength TABLET;ORAL-28 - 3MG;0.03MG Sponsor HETERO LABS Submission history Latest submission status date: 2024-12-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview DROSPIRENONE AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 213034 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DROSPIRENONE; ETHINYL ESTRADIOL Form and strength TABLET;ORAL-28 - 3MG;0.03MG Sponsor HETERO LABS Submission history Latest submission status date: 2024-12-26 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.