TheraRadar
Data updated: May 26, 2026

CYCLOMYDRIL (cyclopentolate hydrochloride)

Ophthalmology Approved 1975-09-12

CYCLOMYDRIL is indicated for the treatment of Mydriasis.

Source: FDA Label • Novartis
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1
Indication
--
Phase 3 Trials
50
Years on Market

Details

Status
Prescription
First Approved
1975-09-12
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Novartis
Active Ingredient: CYCLOPENTOLATE HYDROCHLORIDE , PHENYLEPHRINE HYDROCHLORIDE

CYCLOMYDRIL Approval History

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Original
New Indication
New Form
Label Update
27 FDA actions from 1975 to 2025
May 2025 SUPPL
Label · Labeling
Oct 2003 SUPPL
Label · Labeling
Dec 2002 SUPPL
Mfg · Manufacturing (CMC)

What CYCLOMYDRIL Treats

1 indications

CYCLOMYDRIL is approved for 1 conditions since its original approval in 1975. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Mydriasis
Source: FDA Label

CYCLOMYDRIL Competitive Set

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Indication competitors

4

Same indication, different mechanism — what else might this patient receive?

RYZUMVI
FAMYGEN LIFE
2023 1 indic.
ISOPTO ATROPINE
Novartis
2016 3 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CYCLOMYDRIL

3 of 6

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AKPENTOLATE
CYCLOPENTOLATE HYDROCHLORIDE
1 shared
RISING
Shared indications:
Mydriasis
CYCLOGYL
CYCLOPENTOLATE HYDROCHLORIDE
1 shared
Novartis
Shared indications:
Mydriasis
ISOPTO ATROPINE
ATROPINE SULFATE
1 shared
Novartis
Shared indications:
Mydriasis
View all 6 similar drugs Pro
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Active Pipeline

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Key Completed Trials

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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.

CYCLOMYDRIL FDA Label Details

Indications & Usage

CYCLOMYDRIL is indicated for the treatment of Mydriasis.

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Data Sources

FDA Approval: ANDA084300 → Label: DailyMed → Trials: ClinicalTrials.gov →

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