Data updated: Jun 17, 2026
TERAZOL 3 (terconazole)
Infectious Disease
Approved 1988-05-24
2
Indications
--
Phase 3 Trials
38
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1988-05-24
- Routes
- VAGINAL
- Dosage Forms
- SUPPOSITORY, CREAM
TERAZOL 3 Approval History
1989
1990
1991
1992
1993
1994
1995
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
45 FDA actions from 1988 to 2014
Jul 2013 SUPPL
Mfg · Manufacturing (CMC)
Oct 2002 SUPPL
Mfg
Apr 2002 SUPPL
Mfg
Dec 2001 SUPPL
Mfg
Sep 2001 SUPPL
Mfg
Mar 2001 SUPPL
Mfg
Nov 1999 SUPPL
Mfg
Oct 1999 SUPPL
Mfg
Oct 1999 SUPPL
Mfg
Sep 1999 SUPPL
Mfg
Oct 1998 SUPPL
Mfg
Jul 1997 SUPPL
Label
Oct 1994 SUPPL
Mfg
Feb 1993 SUPPL
Mfg
Sep 1992 SUPPL
Mfg
Mar 1992 SUPPL
Mfg
Feb 1991 ORIGINAL
Update
Aug 1990 SUPPL
Mfg
Nov 1989 SUPPL
Label
Jul 1989 SUPPL
Mfg
Nov 1988 SUPPL
Label
May 1988 ORIGINAL
New Form
What TERAZOL 3 Treats
2 FDA approvalsOriginally approved for its first indication in 1988 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (May 1988)
- • Approved indication (Feb 1991)
Johnson & Johnson's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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LAZCLUZE
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1 designation
TALVEY
2023 TALQUETAMAB-TGVS
5 designations
TECVAYLI
2022 TECLISTAMAB-CQYV
5 designations
RYBREVANT
2021 AMIVANTAMAB-VMJW
4 designations
BALVERSA
2019 ERDAFITINIB
4 designations
ERLEADA
2018 APALUTAMIDE
2 designations
TREMFYA
2017 GUSELKUMAB
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02308007 SMART GIVES results posted | MTC-001 (Trial 3) | Ph 3 | completed | Multi-Center Study of New Medications to Treat Vaginal Infections |
| NCT02308046 SMART GIVES results posted | MTC-001 (Trial 1) | Ph 3 | completed | Multi-Center Study of New Medications to Treat Vaginal Infections |
🔬
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.
TERAZOL 3 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.