Tropicamide

Sold as Mydriacyl. Every FDA application for this active ingredient: 1 branded and 14 generic.

As of Nov 15, 2026, FDA lists 15 applications for Tropicamide (sold as Mydriacyl), first approved Feb 23, 1960, with 0 new uses approved and 0 published complete response letters.

First approved: Feb 23, 1960
Applications: 15
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $3K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Tropicamide	Part D	$3K	-73%	221

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TROPICAMIDE 1% EYE DROP: $0.529 per MLGeneric · +8% in a year
TROPICAMIDE 1% EYE DROPS: $0.529 per MLGeneric · +8% in a year

Clinical Trials

7 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


ML Models Predicting Cycloplegic Refractive Error Based on Non-Cycloplegic Parameters in Myopic AdultsRefractive Errors, Cycloplegic Refraction · Second Affiliated Hospital of Nanchang University	—	Recruiting	Jul 8, 2026
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
Subthreshold Micropulse Laser Therapy (SML) in Retinitis PigmentosaRetinitis Pigmentosa (RP) · Marta P. Wiącek	Not applicable	Enrolling by invitation	Jul 28, 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
Long-term Ophthalmic Outcomes in Ex-premature InfantsRetinopathy of Prematurity (ROP), Premature Birth · Erasmus Medical Center	—	Not yet recruiting	Oct 18, 2024
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
Chromosome 18 Clinical Research CenterChromosome Aberrations, Growth Hormone Deficiency · The University of Texas Health Science Center at San Antonio	—	Recruiting	Sep 27, 2005

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 23, 1960	MydriacylNDA 12111 · New molecular entity	Alcon	0	Discontinued
Dec 6, 1974	MydriacylANDA 84305	Sandoz	24	Marketed
Dec 6, 1974	MydriacylANDA 84306	Alcon Labs Inc	26	Marketed
Jul 30, 1982	TropicamideANDA 87636	Miza Pharms USA	8	Discontinued
Aug 9, 1982	TropicamideANDA 87637	Miza Pharms USA	7	Discontinued
Aug 28, 1985	TropicamideANDA 88447	Epic Pharma LLC	1	Discontinued
Dec 28, 1990	TropicamideANDA 89172	Alcon Pharms Ltd	5	Discontinued
Jul 27, 1994	TropicamideANDA 40064	Bausch And Lomb	13	Marketed
Jul 27, 1994	TropicamideANDA 40067	Bausch And Lomb	13	Marketed
Sep 29, 2000	TropicacylANDA 40314	Epic Pharma LLC	2	Marketed
Sep 29, 2000	TropicacylANDA 40315	Rising	2	Marketed
Dec 12, 2019	TropicamideANDA 207524	Somerset Theraps LLC	0	Marketed
—	MydriafairANDA 88230	Pharmafair	0	Discontinued
—	MydriafairANDA 88274	Pharmafair	0	Discontinued
—	TropicamideANDA 89171	Watson Labs	0	Discontinued

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