Data updated: May 26, 2026
NORGESTREL AND ETHINYL ESTRADIOL (ethinyl estradiol)
Women's Health
Approved 2016-06-21
2
Indications
--
Phase 3 Trials
9
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-06-21
- Routes
- ORAL-28
- Dosage Forms
- TABLET
NORGESTREL AND ETHINYL ESTRADIOL Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2016 to 2017
Aug 2017 SUPPL
Label · Labeling
May 2017 ORIGINAL
Update
Jun 2016 ORIGINAL
Update · Not Applicable
What NORGESTREL AND ETHINYL ESTRADIOL Treats
2 FDA approvalsOriginally approved for its first indication in 2016 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Jun 2016)
- • Approved indication (May 2017)
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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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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.
NORGESTREL AND ETHINYL ESTRADIOL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.