Data updated: Mar 10, 2026
DIGOXIN
DIGOXIN
Approved 1975-10-24
15
Indications
--
Phase 3 Trials
50
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1975-10-24
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE, ELIXIR
Companies
IMPAX LABS Pfizer AMICI PHARMA STEVENS J Aurobindo Pharma ABRAXIS PHARM VISTAPHARM LLC Sun Pharma Hikma RISING Novartis NOVITIUM PHARMA
Active Ingredient: DIGOXIN
Website: ↗
DIGOXIN Approval History
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What DIGOXIN Treats
15 FDA approvalsOriginally approved for its first indication in 1975 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Oct 1975)
- • Approved indication (Jul 1976)
- • Approved indication (May 1996)
- • Approved indication (Aug 1998)Letter
- • Approved indication (Dec 1999)Letter
- • Approved indication (Jul 2002)Label Letter
- • Approved indication (Jan 2003)
- • Approved indication (Aug 2003)
- • Approved indication (Aug 2004)Label Letter
- • Approved indication (Oct 2007)
- • Approved indication (Jul 2009)
- • Approved indication (Oct 2019)Letter
- • Approved indication (Nov 2021)
- • Approved indication (Feb 2022)Letter
- • Approved indication (Mar 2022)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
DIGOXIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.