Data updated: Mar 10, 2026
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE
Approved 1972-02-14
54
Indications
--
Phase 3 Trials
54
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1972-02-14
- Routes
- INJECTION, TOPICAL, ORAL
- Dosage Forms
- INJECTABLE, SOLUTION, JELLY
Companies
WATSON LABS RISING PAI HOLDINGS PHARM HUONS INTL MEDICATION LUITPOLD ASPIRO AFAXYS Aurobindo Pharma SENTISS GD SEARLE LLC ABRAXIS PHARM PHARMOBEDIENT NOVITIUM PHARMA MANKIND PHARMA BELMORA LLC COSETTE Pfizer DELL LABS ABBOTT Hikma SPECTRA MDCL DEVICES THE J MOLNER ANTHEA PHARMA LYPHOMED MILES BEL MAR EUGIA PHARMA RUBICON RESEARCH LANNETT CO INC WATSON LABS INC WEST-WARD PHARMS INT YILING SUN PHARMA CANADA ELKINS SINN EPIC PHARMA LLC Fresenius Kabi AM REGENT PACO B BRAUN MEDICAL
Active Ingredient: LIDOCAINE HYDROCHLORIDE
Website: ↗
LIDOCAINE HYDROCHLORIDE Approval History
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What LIDOCAINE HYDROCHLORIDE Treats
54 FDA approvalsOriginally approved for its first indication in 1972 . Covers 54 distinct patient populations.
- Other (54)
Other
(54 approvals)- • Approved indication (Feb 1972)
- • Approved indication (Feb 1972)
- • Approved indication (Feb 1972)
- • Approved indication (Jun 1972)
- • Approved indication (Oct 1972)
- • Approved indication (Dec 1972)
- • Approved indication (Dec 1973)
- • Approved indication (Feb 1974)
- • Approved indication (Mar 1975)
- • Approved indication (Apr 1975)
- • Approved indication (Aug 1975)
- • Approved indication (Sep 1975)
- • Approved indication (Jul 1976)
- • Approved indication (Oct 1976)
- • Approved indication (Oct 1976)
- • Approved indication (Dec 1976)
- • Approved indication (Mar 1977)
- • Approved indication (Aug 1979)
- • Approved indication (Dec 1979)
- • Approved indication (Nov 1982)
- • Approved indication (Feb 1983)
- • Approved indication (May 1984)
- • Approved indication (May 1984)
- • Approved indication (Apr 1985)
- • Approved indication (Jul 1985)
- • Approved indication (May 1988)
- • Approved indication (Jun 1989)
- • Approved indication (Apr 1993)
- • Approved indication (Jun 1995)
- • Approved indication (Jul 1995)
- • Approved indication (Feb 2003)
- • Approved indication (Feb 2007)
- • Approved indication (Sep 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Mar 2011)
- • Approved indication (Mar 2014)
- • Approved indication (Apr 2014)
- • Approved indication (Aug 2015)
- • Approved indication (Oct 2017)
- • Approved indication (Apr 2018)
- • Approved indication (Aug 2018)
- • Approved indication (May 2020)
- • Approved indication (Nov 2021)
- • Approved indication (Mar 2022)
- • Approved indication (May 2022)
- • Approved indication (Jun 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Mar 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Apr 2024)
- • Approved indication (Apr 2025) New
- • Approved indication (Jul 2025) 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 HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.