Data updated: Mar 10, 2026
LIDOCAINE
LIDOCAINE
Approved 1971-06-30
27
Indications
--
Phase 3 Trials
54
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1971-06-30
- Routes
- TOPICAL
- Dosage Forms
- OINTMENT, PATCH
Companies
BELMORA LLC USPHARMA NOVEN PHARMS INC COSETTE RISING IBSA SUN PHARMA CANADA NAL PHARM AMNEAL PHARMS ALEMBIC DIFGEN PHARMS Teva GLENMARK PHARMS LTD ALKEM LABS LTD STRIDES PHARMA GENEYORK PHARMS CHARTWELL RX MACLEODS PHARMS LTD Aurobindo Pharma SEPTODONT INC PHARMOBEDIENT VITRUVIAS THERAP AMNEAL FOUGERA PHARMS INC ENCUBE QUAGEN
Active Ingredient: LIDOCAINE
Website: ↗
LIDOCAINE Approval History
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What LIDOCAINE Treats
27 FDA approvalsOriginally approved for its first indication in 1971 . Covers 27 distinct patient populations.
- Other (27)
Other
(27 approvals)- • Approved indication (Jun 1971)
- • Approved indication (Jun 1972)
- • Approved indication (Aug 1981)
- • Approved indication (May 2011)
- • Approved indication (Aug 2012)Letter
- • Approved indication (Aug 2015)Letter
- • Approved indication (Feb 2016)Letter
- • Approved indication (Sep 2016)
- • Approved indication (Mar 2017)
- • Approved indication (Sep 2017)
- • Approved indication (Sep 2017)
- • Approved indication (Jan 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Oct 2019)
- • Approved indication (Mar 2020)
- • Approved indication (Apr 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Jan 2021)
- • Approved indication (Apr 2021)
- • Approved indication (Apr 2021)
- • Approved indication (Jun 2024)
- • Approved indication (Mar 2025) New
- • Approved indication (Oct 2025) New
- • Approved indication (Feb 2026) New
🔬
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.
LIDOCAINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.