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General MedicationsORALStandard

LO/OVRAL FE

ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE

Standard Dose
0.03MG,0.3MG;75MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LO/OVRAL FE is listed in Drugs@FDA under application 018206 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE Form and strength TABLET;ORAL - 0.03MG,0.3MG;75MG Sponsor CADENCE HEALTH Submission history Latest submission status date: 2022-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview LO/OVRAL FE is listed in Drugs@FDA under application 018206 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE Form and strength TABLET;ORAL - 0.03MG,0.3MG;75MG Sponsor CADENCE HEALTH 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.