BALZIVA-28

Post-LOE

norethindrone and ethinyl estradiol

Teva

ANDAORAL-28TABLET

Approved

Apr 2004

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

BALZIVA-28 (norethindrone and ethinyl estradiol) by Teva is clinical pharmacology combination oral contraceptives act by suppression of gonadotropins. Approved for pregnancy in women. First approved in 2004.

Drug data last refreshed 19h ago

Mechanism of Action

CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the…

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.