TheraRadar
Data updated: May 26, 2026

CYCLOGYL (cyclopentolate hydrochloride)

Ophthalmology Approved 1974-07-31

CYCLOGYL is indicated for the treatment of Mydriasis; Cycloplegia.

Source: FDA Label • Novartis
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1
Indication
--
Phase 3 Trials
51
Years on Market

Details

Status
Prescription
First Approved
1974-07-31
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Novartis
Active Ingredient: CYCLOPENTOLATE HYDROCHLORIDE

CYCLOGYL Approval History

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Original
New Indication
New Form
Label Update
84 FDA actions from 1974 to 2003
Oct 2003 SUPPL
Label · Labeling
Dec 2002 SUPPL
Mfg · Manufacturing (CMC)
Oct 2002 SUPPL
Mfg · Manufacturing (CMC)

What CYCLOGYL Treats

2 indications

CYCLOGYL is approved for 2 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Mydriasis
  • Cycloplegia
Source: FDA Label

CYCLOGYL 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 CYCLOGYL

3 of 6

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

AKPENTOLATE
CYCLOPENTOLATE HYDROCHLORIDE
2 shared
RISING
Shared indications:
MydriasisCycloplegia
ISOPTO ATROPINE
ATROPINE SULFATE
2 shared
Novartis
Shared indications:
MydriasisCycloplegia
MYDRIACYL
TROPICAMIDE
2 shared
Novartis
Shared indications:
MydriasisCycloplegia
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

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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.

CYCLOGYL FDA Label Details

Indications & Usage

CYCLOGYL is indicated for the treatment of Mydriasis; Cycloplegia.

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Data Sources

FDA Approval: ANDA084110 → Label: DailyMed → Trials: ClinicalTrials.gov →

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