Data updated: Mar 10, 2026
NORGESTIMATE AND ETHINYL ESTRADIOL
ETHINYL ESTRADIOL
Approved 2006-08-17
14
Indications
--
Phase 3 Trials
19
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2006-08-17
- Routes
- ORAL-28
- Dosage Forms
- TABLET
Companies
Website: ↗
NORGESTIMATE AND ETHINYL ESTRADIOL Approval History
Loading approval history...
What NORGESTIMATE AND ETHINYL ESTRADIOL Treats
14 FDA approvalsOriginally approved for its first indication in 2006 . Covers 14 distinct patient populations.
- Other (14)
Other
(14 approvals)- • Approved indication (Aug 2006)
- • Approved indication (Mar 2011)
- • Approved indication (Jun 2011)
- • Approved indication (Apr 2012)
- • Approved indication (Jun 2012)
- • Approved indication (Apr 2015)
- • Approved indication (Sep 2015)
- • Approved indication (Oct 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Jan 2016)
- • Approved indication (Feb 2016)
- • Approved indication (Apr 2016)
- • Approved indication (May 2016)Letter
- • Approved indication (Oct 2016)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
NORGESTIMATE AND ETHINYL ESTRADIOL FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.