Data updated: Mar 10, 2026
SPIRONOLACTONE
SPIRONOLACTONE
Approved 1980-05-07
19
Indications
--
Phase 3 Trials
45
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1980-05-07
- Routes
- ORAL
- Dosage Forms
- TABLET, SUSPENSION
Companies
IVAX PHARMS ZYDUS PHARMS AMNEAL Teva OXFORD PHARMS ANNORA PHARMA MUTUAL PHARM PUREPAC PHARM ACCORD HLTHCARE Viatris WATSON LABS ASCOT CHARTWELL RX UPSHER SMITH LEDERLE VANGARD AMNEAL PHARMS WARNER CHILCOTT PHARMOBEDIENT Sun Pharma JUBILANT GENERICS HETERO LABS LTD III SUPERPHARM Aurobindo Pharma GRAVITI PHARMS
Active Ingredient: SPIRONOLACTONE
Website: ↗
SPIRONOLACTONE Approval History
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What SPIRONOLACTONE Treats
19 FDA approvalsOriginally approved for its first indication in 1980 . Covers 19 distinct patient populations.
- Other (19)
Other
(19 approvals)- • Approved indication (May 1980)
- • Approved indication (Jul 1980)
- • Approved indication (Jan 1981)
- • Approved indication (Feb 1981)
- • Approved indication (Feb 1981)
- • Approved indication (Feb 1982)
- • Approved indication (Jul 1986)
- • Approved indication (Jul 1999)Letter
- • Approved indication (Aug 2001)Label Letter
- • Approved indication (Aug 2006)
- • Approved indication (Jul 2010)
- • Approved indication (Mar 2014)
- • Approved indication (Apr 2014)
- • Approved indication (Sep 2016)
- • Approved indication (Jul 2018)
- • Approved indication (Sep 2023)Letter
- • Approved indication (Jan 2025)
- • Approved indication (Feb 2025)
- • Approved indication (Jul 2025) New
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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.
SPIRONOLACTONE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.