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General MedicationsORAL-21Generic

ENPRESSE-21

ETHINYL ESTRADIOL; LEVONORGESTREL

Standard Dose
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ENPRESSE-21 is listed in Drugs@FDA under application 075809 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL-21 - 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG Sponsor DURAMED PHARMS BARR Submission history Latest submission status date: 2022-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview ENPRESSE-21 is listed in Drugs@FDA under application 075809 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL Form and strength TABLET;ORAL-21 - 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG Sponsor DURAMED PHARMS BARR Submission history Latest submission status date: 2022-04-29 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Discontinued
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
ENPRESSE-21 (ETHINYL ESTRADIOL; LEVONORGESTREL) | Drug Monograph | MedicHelpline