TheraRadar
Data updated: May 26, 2026

TAMBOCOR (flecainide acetate)

Cardiovascular Approved 1985-10-31
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
40
Years on Market

Details

Status
Discontinued
First Approved
1985-10-31
Routes
ORAL
Dosage Forms
TABLET

Companies

ALVOGEN
Active Ingredient: FLECAINIDE ACETATE

TAMBOCOR Approval History

1986
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Original
New Indication
New Form
Label Update
16 FDA actions from 1985 to 2016
Sep 2016 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Apr 2000 SUPPL
Mfg · Manufacturing (CMC)
Sep 1999 SUPPL
Mfg · Manufacturing (CMC)

What TAMBOCOR Treats

1 FDA approvals

Originally approved for its first indication in 1985 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03539302 INSTANT results posted FLE-002 Ph 2 completed INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)
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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.

TAMBOCOR FDA Label Details

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Data Sources

FDA Approval: NDA018830 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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