TheraRadar
Data updated: Mar 29, 2026

MYDCOMBI

PHENYLEPHRINE HYDROCHLORIDE
Approved 2023-05-05
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Discontinued
First Approved
2023-05-05
Routes
OPHTHALMIC
Dosage Forms
SPRAY, METERED

Companies

EYENOVIA
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE , TROPICAMIDE

MYDCOMBI Approval History

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What MYDCOMBI Treats

1 FDA approvals

Originally approved for its first indication in 2023 .

  • Other (1)
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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.

MYDCOMBI FDA Label Details

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MYDCOMBI Patents & Exclusivity

Latest Patent: Jul 2031
Exclusivity: May 2026

Patents (3 active)

US11398306 Expires Jul 15, 2031
US10839960 Expires Jul 15, 2031
US11839487 Expires Jul 15, 2031

Exclusivity

NP Until May 2026
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA215352 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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