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General MedicationsORAL-28Generic

ESTROSTEP FE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Standard Dose
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ESTROSTEP FE is listed in Drugs@FDA under application 020130 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL-28 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor APIL Submission history Latest submission status date: 2022-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview ESTROSTEP FE is listed in Drugs@FDA under application 020130 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL-28 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor APIL Submission history Latest submission status date: 2022-04-29 00:00:00.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.