General MedicationsORAL-21Standard

AUROVELA 1/20

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Standard Dose

0.02MG;1MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview AUROVELA 1/20 is listed in Drugs@FDA under application 207506 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL-21 - 0.02MG;1MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-03-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview AUROVELA 1/20 is listed in Drugs@FDA under application 207506 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Form and strength TABLET;ORAL-21 - 0.02MG;1MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-03-28 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.