Data updated: Mar 10, 2026
METRONIDAZOLE
METRONIDAZOLE
Approved 1981-10-30
54
Indications
--
Phase 3 Trials
44
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1981-10-30
- Routes
- ORAL, TOPICAL, VAGINAL, INJECTION
- Dosage Forms
- CAPSULE, GEL, TABLET, EXTENDED RELEASE, TABLET, CREAM, INJECTABLE, LOTION
Companies
ABLE FOUGERA PHARMS ALEMBIC LNK Lupin COSETTE HALSEY MUTUAL PHARM ENCUBE GLENMARK PHARMS LTD ZYDUS LIFESCIENCES SUPERPHARM WATSON LABS INNOGENIX TARO SOMERSET THERAPS LLC CHARTWELL RX Hikma UNICHEM PADAGIS ISRAEL Aurobindo Pharma STRIDES PHARMA CHARTWELL MOLECULES CADILA PHARMS LTD PLIVA ABRAXIS PHARM CADILA INTL MEDICATION ALEMBIC PHARMS LTD ABBOTT NOVITIUM PHARMA Teva IVAX SUB TEVA PHARMS FOSUN PHARMA SOLARIS PHARMA CORP SCIEGEN PHARMS WATSON LABS INC FLAMINGO PHARMS
Active Ingredient: METRONIDAZOLE
Website: ↗
METRONIDAZOLE Approval History
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What METRONIDAZOLE Treats
54 FDA approvalsOriginally approved for its first indication in 1981 . Covers 54 distinct patient populations.
- Other (54)
Other
(54 approvals)- • Approved indication (Oct 1981)
- • Approved indication (Mar 1982)
- • Approved indication (Sep 1982)
- • Approved indication (Oct 1982)
- • Approved indication (Feb 1983)
- • Approved indication (Aug 1983)
- • Approved indication (Nov 1983)
- • Approved indication (Mar 1984)
- • Approved indication (Apr 1984)
- • Approved indication (Dec 1984)
- • Approved indication (Dec 1984)
- • Approved indication (Dec 1984)
- • Approved indication (Jan 1985)
- • Approved indication (Feb 1985)
- • Approved indication (Jul 1986)
- • Approved indication (Jun 2003)
- • Approved indication (Jun 2003)
- • Approved indication (Nov 2003)
- • Approved indication (Jan 2004)
- • Approved indication (May 2004)Letter
- • Approved indication (May 2006)Letter
- • Approved indication (Jun 2006)Letter
- • Approved indication (Jul 2006)
- • Approved indication (Jul 2006)
- • Approved indication (Oct 2006)Letter
- • Approved indication (Dec 2007)
- • Approved indication (Mar 2009)
- • Approved indication (Jun 2009)
- • Approved indication (May 2010)
- • Approved indication (Jan 2011)
- • Approved indication (Jul 2011)
- • Approved indication (Jan 2014)
- • Approved indication (May 2015)
- • Approved indication (Sep 2015)
- • Approved indication (May 2016)
- • Approved indication (May 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Mar 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Sep 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Jul 2019)
- • Approved indication (Sep 2021)
- • Approved indication (Oct 2021)
- • Approved indication (Jan 2022)
- • Approved indication (Jan 2023)
- • Approved indication (Apr 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Mar 2024)Letter
- • Approved indication (Oct 2024)
- • Approved indication (Dec 2024)
- • Approved indication (Jul 2025) New
- • Approved indication (Feb 2026) 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.
METRONIDAZOLE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.