What is OSHIH used for?

OSHIH is an FDA-approved medication. See full prescribing information for approved uses.

Is OSHIH FDA approved?

Yes, OSHIH is FDA approved (first approved 2023-12-06) and manufactured by Aurobindo Pharma.

OSHIH is manufactured by Aurobindo Pharma.

Data updated: May 26, 2026

OSHIH (ethinyl estradiol)

Women's Health Approved 2023-12-06

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 2023-12-06
Routes: ORAL
Dosage Forms: TABLET

Companies

Aurobindo Pharma

Active Ingredient: ETHINYL ESTRADIOL , NORETHINDRONE ACETATE

OSHIH Approval History

2024

2025

2026

Original

New Indication

New Form

Label Update

1 FDA actions from 2023 to 2023

Dec 2023 ORIGINAL

Update

What OSHIH Treats

1 FDA approvals

Originally approved for its first indication in 2023 .

Other (1)

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Clinical Trial Registry

2 trials

Trial	Sponsor ID	Phase	Status	Title
NCT07340190	CDAK539A12102 2025-521000-22-00	Ph 1	not yet recruiting	A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
NCT06039826	18533 J1I-MC-GZBV	Ph 1	completed	A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

| Show all trials (incl. adjuvant)

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OSHIH FDA Label Details

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Data Sources

FDA Approval: ANDA216558 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

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