TheraRadar
Data updated: May 26, 2026

CYCLAFEM 0.5/35 (ethinyl estradiol)

Women's Health Approved 2015-12-16
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2015-12-16
Routes
ORAL-28
Dosage Forms
TABLET

Companies

PH HEALTH
Active Ingredient: ETHINYL ESTRADIOL , NORETHINDRONE

CYCLAFEM 0.5/35 Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2015 to 2022
Apr 2022 SUPPL
Label · Labeling
Feb 2022 SUPPL
Label · Labeling
Dec 2015 ORIGINAL
Update

What CYCLAFEM 0.5/35 Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • 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

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

CYCLAFEM 0.5/35 FDA Label Details

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Data Sources

FDA Approval: ANDA203413 → Trials: ClinicalTrials.gov →

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