Data updated: Mar 10, 2026
LEVOFLOXACIN
LEVOFLOXACIN
Approved 2010-12-20
20
Indications
--
Phase 3 Trials
15
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2010-12-20
- Routes
- INJECTION, ORAL, OPHTHALMIC
- Dosage Forms
- INJECTABLE, TABLET, SOLUTION/DROPS, SOLUTION
Companies
PHARMOBEDIENT MACLEODS PHARMS LTD WATSON LABS TEVA CHARTWELL MOLECULAR NATCO PHARMA Pfizer Viatris CHARTWELL RX EUGIA PHARMA AVET LIFESCIENCES Teva ZYDUS LIFESCIENCES Lupin SCIEGEN PHARMS Aurobindo Pharma Novartis HEC PHARM RUBICON RESEARCH RISING WATSON LABS INC LANNETT CO INC TORRENT PHARMS NOVITIUM PHARMA GLENMARK PHARMS LTD HETERO LABS LTD V MICRO LABS LTD INDIA Dr. Reddy's ORBION PHARMS Hikma Baxter GLAND ZYDUS PHARMS Apotex JUBILANT GENERICS SICOR PHARMS
Active Ingredient: LEVOFLOXACIN
Website: ↗
LEVOFLOXACIN Approval History
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What LEVOFLOXACIN Treats
20 FDA approvalsOriginally approved for its first indication in 2010 . Covers 20 distinct patient populations.
- Other (20)
Other
(20 approvals)- • Approved indication (Dec 2010)
- • Approved indication (Feb 2011)
- • Approved indication (Jun 2011)
- • Approved indication (Sep 2011)
- • Approved indication (Jan 2012)
- • Approved indication (Mar 2012)
- • Approved indication (Mar 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Jan 2013)
- • Approved indication (Jun 2013)
- • Approved indication (Nov 2013)
- • Approved indication (Jan 2015)Letter
- • Approved indication (Jun 2015)Letter
- • Approved indication (Aug 2015)Letter
- • Approved indication (Jun 2017)
- • Approved indication (Dec 2017)
- • Approved indication (May 2018)
- • Approved indication (Feb 2019)
- • Approved indication (Feb 2019)Letter
- • Approved indication (Apr 2020)
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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.
LEVOFLOXACIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.