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General MedicationsORALStandard

SIMPESSE

ETHINYL ESTRADIOL; LEVONORGESTREL

Standard Dose
0.03MG,0.01MG;0.15MG,N/A
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SIMPESSE is listed in Drugs@FDA under application 206851 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL - 0.03MG,0.01MG;0.15MG,N/A Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2025-06-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview SIMPESSE is listed in Drugs@FDA under application 206851 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL - 0.03MG,0.01MG;0.15MG,N/A Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2025-06-18 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.