General MedicationsORALStandard

NORMINEST FE

ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE

Standard Dose

0.035MG;0.5MG;75MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview NORMINEST FE is listed in Drugs@FDA under application 017948 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE Form and strength TABLET;ORAL - 0.035MG;0.5MG;75MG Sponsor GD SEARLE LLC Submission history Latest submission status date: 2022-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview NORMINEST FE is listed in Drugs@FDA under application 017948 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE Form and strength TABLET;ORAL - 0.035MG;0.5MG;75MG Sponsor GD SEARLE LLC Submission history Latest submission status date: 2022-04-29 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.