Sold as Mydcombi. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Phenylephrine Hydrochloride; Tropicamide (sold as Mydcombi), first approved May 5, 2023, with 0 new uses approved and 1 published complete response letter.
| Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.Adverse Drug Effect, Phenylephrine · Instituto de Oftalmología Fundación Conde de Valenciana | — | Recruiting | Sep 17, 2025 |
| Assessing Patient Comfort, Anxiety, and Satisfaction During CR Comparing Conventional Drops With ROCCycloplegic Paralysis of Accommodation · Superior University | Not applicable | Active, not recruiting | Apr 6, 2025 |
| Contribution of the Kinematic Theory in the Early Differential Diagnosis of the Parkinson's DiseaseParkinson Disease, Healthy · Centre hospitalier de l'Université de Montréal (CHUM) | — | Recruiting | Dec 8, 2023 |
| Letter | Product | Now |
|---|---|---|
| Oct 22, 2021 | NDA 215352 | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
