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General MedicationsORALStandard

ICLEVIA

ETHINYL ESTRADIOL; LEVONORGESTREL

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

Approval overview ICLEVIA is listed in Drugs@FDA under application 206850 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL - 0.03MG;0.15MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2024-06-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview ICLEVIA is listed in Drugs@FDA under application 206850 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL - 0.03MG;0.15MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2024-06-24 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.