Data updated: May 26, 2026
UNIVASC (moexipril hydrochloride)
Cardiovascular
Approved 1995-04-19
1
Indication
--
Phase 3 Trials
31
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1995-04-19
- Routes
- ORAL
- Dosage Forms
- TABLET
UNIVASC Approval History
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
48 FDA actions from 1995 to 2012
Dec 2002 SUPPL
Mfg
Oct 2001 SUPPL
Mfg
Sep 2001 SUPPL
Mfg
Mar 2001 SUPPL
Mfg
Jul 2000 SUPPL
Mfg
Feb 2000 SUPPL
Label
Oct 1999 SUPPL
Mfg
Feb 1999 SUPPL
Mfg
Sep 1998 SUPPL
Mfg
Apr 1998 SUPPL
Label
Nov 1996 SUPPL
Mfg
Sep 1996 SUPPL
Mfg
Jul 1996 SUPPL
Mfg
Jan 1996 SUPPL
Mfg
Oct 1995 SUPPL
Mfg
Apr 1995 ORIGINAL
New Drug
What UNIVASC Treats
1 FDA approvalsOriginally approved for its first indication in 1995 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 1995)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
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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.
UNIVASC FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.