Data updated: Mar 10, 2026
ISONIAZID
ISONIAZID
Approved 1952-11-17
21
Indications
--
Phase 3 Trials
73
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1952-11-17
- Routes
- ORAL, Injection, INJECTION
- Dosage Forms
- TABLET, Injectable, INJECTABLE, SYRUP
Companies
IMPAX LABS HALSEY Hikma QUAD PHARMS PUREPAC PHARM PHOENIX LABS NY GENUS PANRAY EPIC PHARMA LLC THEPHARMANETWORK LLC WHITEWORTH TOWN PLSN PERRIGO Novartis Sun Pharma WATSON LABS CHARTWELL RX IVAX SUB TEVA PHARMS PHARMAVITE Eli Lilly MK LABS OMNIVIUM PHARMS DURAMED PHARMS BARR NEXGEN PHARMA INC CMP PHARMA INC
Active Ingredient: ISONIAZID
Website: ↗
ISONIAZID Approval History
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What ISONIAZID Treats
21 FDA approvalsOriginally approved for its first indication in 1952 . Covers 21 distinct patient populations.
- Other (21)
Other
(21 approvals)- • Approved indication (Nov 1952)
- • Approved indication (Nov 1970)
- • Approved indication (Apr 1971)
- • Approved indication (Feb 1972)
- • Approved indication (Feb 1972)
- • Approved indication (Mar 1972)
- • Approved indication (Aug 1972)
- • Approved indication (Aug 1973)
- • Approved indication (Jan 1974)
- • Approved indication (Oct 1974)
- • Approved indication (Dec 1975)
- • Approved indication (May 1976)
- • Approved indication (Jul 1976)
- • Approved indication (Sep 1977)
- • Approved indication (Jul 1981)
- • Approved indication (Mar 1983)
- • Approved indication (Nov 1983)
- • Approved indication (Jun 1997)
- • Approved indication (Jul 1997)
- • Approved indication (Jul 2005)
- • Approved indication (Oct 2014)
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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.
ISONIAZID FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.