General MedicationsORAL-21Generic

ESTROSTEP 21

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0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 21 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-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor APIL Submission history Latest submission status date: 2022-04-29 00:00:00.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 21 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-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor APIL Submission history Latest submission status date: 2022-04-29 00:00:00.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.