TheraRadar
Data updated: May 26, 2026

CELONTIN (methsuximide)

CNS Approved 1957-02-08
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
69
Years on Market

Details

Status
Discontinued
First Approved
1957-02-08
Routes
ORAL
Dosage Forms
CAPSULE

Companies

PARKE DAVIS
Active Ingredient: METHSUXIMIDE

CELONTIN Approval History

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Original
New Indication
New Form
Label Update
32 FDA actions from 1957 to 2011
Jun 2011 SUPPL
Update · REMS
FDA Letter
Oct 2010 SUPPL
Label · Labeling
FDA Letter Label
Apr 2009 SUPPL
Label · Labeling
FDA Letter Label

What CELONTIN Treats

1 FDA approvals

Originally approved for its first indication in 1957 .

  • 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.

CELONTIN FDA Label Details

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Data Sources

FDA Approval: NDA010596 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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