NORTREL 1/35-28

Post-LOE

norethindrone and ethinyl estradiol

Aurobindo Pharma

ANDAORAL-28TABLET

Approved

Feb 1992

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

NORTREL 1/35-28 (norethindrone and ethinyl estradiol) by Aurobindo Pharma is estrogen receptor agonists [moa]. Approved for pregnancy in women. First approved in 1992.

Drug data last refreshed 1w ago

Mechanism of Action

Estrogen Receptor Agonists

Pharmacologic Class:

Estrogen

Indications (1)

pregnancy in women

Clinical Trials (1)

NCT01953809Phase 1Withdrawn

A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women

Started Aug 2014

Infections, Bacterial

Company

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.