Data updated: Mar 10, 2026
TERAZOSIN HYDROCHLORIDE
TERAZOSIN HYDROCHLORIDE
Approved 1998-03-30
13
Indications
--
Phase 3 Trials
27
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1998-03-30
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
Companies
IVAX SUB TEVA PHARMS AJANTA PHARMA LTD Novartis CHARTWELL RX BIONPHARMA PHARMOBEDIENT JUBILANT CADISTA HERITAGE PHARMA AVET Teva RANBAXY LABS LTD Hikma SENORES PHARMS
Active Ingredient: TERAZOSIN HYDROCHLORIDE
Website: ↗
TERAZOSIN HYDROCHLORIDE Approval History
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What TERAZOSIN HYDROCHLORIDE Treats
13 FDA approvalsOriginally approved for its first indication in 1998 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Mar 1998)
- • Approved indication (Dec 1998)Label Letter
- • Approved indication (Feb 2000)Label Letter
- • Approved indication (Apr 2000)Label Letter
- • Approved indication (Apr 2000)Label Letter
- • Approved indication (May 2000)Label Letter
- • Approved indication (Jul 2000)Letter
- • Approved indication (Dec 2000)Letter
- • Approved indication (Jan 2001)Letter
- • Approved indication (Apr 2001)Letter
- • Approved indication (Aug 2002)
- • Approved indication (Dec 2004)
- • Approved indication (May 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.
TERAZOSIN HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.