TheraRadar
Data updated: May 26, 2026

OPCICON ONE-STEP (levonorgestrel)

Women's Health Approved 2014-09-11
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Over-the-counter
First Approved
2014-09-11
Routes
ORAL
Dosage Forms
TABLET

Companies

Sun Pharma
Active Ingredient: LEVONORGESTREL

OPCICON ONE-STEP Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2014 to 2016
May 2016 SUPPL
Label · Labeling
Sep 2014 ORIGINAL
Update

What OPCICON ONE-STEP Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
📋

Clinical Trial Registry

15 trials
Trial Sponsor ID Phase Status Title
NCT03537768 CCN013C Ph 4 terminated Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg
NCT06727734 UW 24-054 Ph 3 recruiting Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception
NCT02722421 0234-16-FB 1R01HD085887-01A1 Ph 2 completed Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women
NCT01686126 feMMe feMMe Ph 2 active not recruiting Improving the Treatment for Women With Early Stage Cancer of the Uterus
NCT06492889 8007 Ph 2, Ph 3 not yet recruiting Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens
NCT02203331 results posted 15832 2013-005090-53 Ph 2 completed Bay98-7196, Dose Finding / POC Study
NCT01789879 0022-14-EP 1R21HD074462-01 Ph 2 completed A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy
NCT00445887 results posted GOG-0214 NCI-2009-00588, 10-01367 Ph 2 completed Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
NCT01623466 ATI-CL21 results posted ATI-CL21 Ph 1, Ph 2 completed Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches
NCT02480647 44827415200005404 Ph 4 completed Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis
NCT02599077 FSantafeBogota Ph 2, Ph 3 suspended Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas
NCT01570244 results posted 1220.56 2011-006061-17 Ph 1 completed Drug-drug Interaction of BI 201335 and Microgynon
NCT02159131 117011 Ph 1 completed Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects
NCT01328184 results posted 1245.41 2010-023432-16 Ph 1 completed Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon
NCT00922233 results posted 10139 Ph 3 completed Pericoital Oral Contraception With Levonorgestrel
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Active Pipeline

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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.

OPCICON ONE-STEP FDA Label Details

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Data Sources

FDA Approval: ANDA202635 → Trials: ClinicalTrials.gov →

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