Data updated: Nov 8, 2026
HALOETTE (ethinyl estradiol) · Dr. Reddy's
Women's Health
Approved 2022-08-05
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
1
Indication
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Prescription
- First Approved
- 2022-08-05
- Routes
- VAGINAL
- Dosage Forms
- RING
HALOETTE Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2022 to 2025
Jan 2025 SUPPL
Label · Labeling
Aug 2022 ORIGINAL
Update
What HALOETTE Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 2022)
📋
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00651807 | P05806 304001 | Ph 2 | terminated | A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806) |
| NCT07340190 | CDAK539A12102 2025-521000-22-00, 2025 | Ph 1 | 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 |
| NCT07339722 | 27789 J6V-MC-OIAB | Ph 1 | recruiting | A Study of LY4515100 in Healthy Participants |
| NCT03978598 LACTO-Rod results posted | 19-049 | Ph 4 | completed | Breastfeeding Etonogestrel Implant Study |
| NCT06039826 | 18533 J1I-MC-GZBV | Ph 1 | completed | A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese |
| NCT02082652 | PRO14010195 | Ph 4 | completed | A Pharmacokinetic Evaluation of Etonogestrel (ENG) Implant and Antiretroviral Therapy |
| NCT02480647 | 44827415200005404 | Ph 4 | completed | Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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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.
HALOETTE FDA Label Details
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.