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General MedicationsORAL-28Standard

LEVONORGESTREL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

Standard Dose
0.02MG;0.1MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LEVONORGESTREL AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 212298 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL-28 - 0.02MG;0.1MG Sponsor HETERO LABS Submission history Latest submission status date: 2023-02-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview LEVONORGESTREL AND ETHINYL ESTRADIOL is listed in Drugs@FDA under application 212298 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL-28 - 0.02MG;0.1MG Sponsor HETERO LABS Submission history Latest submission status date: 2023-02-13 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.