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Data updated: Sep 20, 2026

LIDOCAINE HYDROCHLORIDE · LUITPOLD

Generic · see LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Pain Approved 1948-11-19

LIDOCAINE HYDROCHLORIDE is FDA-approved to treat 2 conditions (same as GLYDO).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
56
Indications
--
Phase 3 Trials
77
Years on Market

Details

Status
Prescription
First Approved
1948-11-19
Routes
INJECTION, TOPICAL, ORAL
Dosage Forms
INJECTABLE, JELLY, SOLUTION

Companies

LUITPOLD INTL MEDICATION PHARMOBEDIENT RISING SUN PHARMA CANADA THE J MOLNER BELMORA LLC GD SEARLE Pfizer B BRAUN MEDICAL ASPIRO ABRAXIS PHARM DELL LABS ELKINS SINN AFAXYS QUAGEN Hikma Aurobindo Pharma LYPHOMED BEL MAR AM REGENT ABBOTT Fresenius Kabi WATSON LABS PACO YILING NOVITIUM PHARMA RUBICON RESEARCH SENTISS MANKIND PHARMA MILES EPIC PHARMA LLC SPECTRA MDCL DEVICES ADAPTIS VIWIT PHARM WEST-WARD PHARMS INT PAI HOLDINGS PHARM EUGIA PHARMA HUONS LANNETT CO INC COSETTE PHARMS NC
Active Ingredient: LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE Approval History

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Original
New Indication
New Form
Label Update
553 FDA actions from 1972 to 2026
Aug 2026 SUPPL
Label · Labeling
Jun 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Label · Labeling

What LIDOCAINE HYDROCHLORIDE Treats

2 indications

LIDOCAINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 1972. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as GLYDO (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

20 trials
Trial Sponsor ID Phase Status Title
NCT07054801 LIMSAH 23-40755 Ph 2 recruiting IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage
NCT03854344 results posted 143321 Ph 4 completed Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
NCT07205757 R 751 Ph 4 recruiting Adding Lidocaine to Custodiol Mixture
NCT06462781 LIGHT 1 23-267 Ph 1 completed Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1
NCT05670236 results posted 32283 Ph 4 completed Effect of Knee Pain on Walking Biomechanics
NCT04524130 610/2563(IRB3) Ph 4 completed Intraoperative Lidocaine and Combined With Ketamine on Opioid After Bariatric Surgery
NCT05201313 LISPRAY 0042698/P/GEN/ARCS Ph 3 completed Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations
NCT03967197 2020-8355 Ph 2, Ph 3 completed Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring
NCT03254394 results posted 201705166 Ph 1, Ph 2 completed Lidocaine for Oxaliplatin-induced Neuropathy
NCT03310970 results posted 201701725 Ph 4 completed Pharmacokinetics of Lidocaine in Healthy Adults
NCT03885596 results posted CA-PS-205 Ph 2 completed Open-Label CA-008 (Vocacapsaicin) in Bunionectomy
NCT03667001 COALAS CTU 17/026 Ph 3 completed Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery
NCT04491474 2020/514/169/20 Ph 4 completed Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Methods at Treatment of Acute Migraine Attack in the Emergency Department
NCT03484650 2344 Ph 3 withdrawn Systemic Lidocaine Infusion for Pain Control in Ventral Hernia
NCT03787147 VR adult 2018-9613 Ph 2 withdrawn Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)
NCT03825016 AS1855 Ph 2 completed Lidocaine Infusion in Hystroscopy
NCT03096444 results posted 20170087 Ph 2 terminated Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine
NCT02120261 USAMPS results posted HSC-MS-14-0072 Ph 4 terminated Using Saline for Myofascial Pain Syndromes (USAMPS)
NCT02689856 Hydro/Lido 143-6151-201 Ph 2 completed Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids
NCT07816159 MIL-SAH p-2026-22097 E-24086-04, Pilot Research Grant Ph 2 not yet recruiting MMA Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal SAH
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

LIDOCAINE HYDROCHLORIDE is FDA-approved to treat 2 conditions — same approved indications as GLYDO.

Looking for the branded version?

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Data Sources

FDA Approval: ANDA083198 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.