TheraRadar
Data updated: May 26, 2026

ROBAXIN (methocarbamol)

Musculoskeletal Approved 1957-07-16

ROBAXIN is indicated for the treatment of Musculoskeletal Conditions.

Source: FDA Label • Hikma
2
Indications
--
Phase 3 Trials
68
Years on Market

Details

Status
Prescription
First Approved
1957-07-16
Routes
IM-IV, ORAL
Dosage Forms
SOLUTION, TABLET

Companies

Active Ingredient: METHOCARBAMOL

ROBAXIN Approval History

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Original
New Indication
New Form
Label Update
67 FDA actions from 1957 to 2019
Mar 2019 SUPPL
Label · Labeling
Mar 2015 SUPPL
Mfg · Manufacturing (CMC)
Aug 2014 SUPPL
Mfg · Manufacturing (CMC)

What ROBAXIN Treats

1 indications

ROBAXIN is approved for 1 conditions since its original approval in 1957. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Musculoskeletal Conditions
Source: FDA Label

Drugs Similar to ROBAXIN

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ATMEKSI
METHOCARBAMOL
1 shared
ROSEMONT PHARMS
Shared indications:
Musculoskeletal Conditions
📋

Clinical Trial Registry

6 trials
Trial Sponsor ID Phase Status Title
NCT05603832 100-CIP02-P Ph 3 completed A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement
NCT05388929 1913843 Ph 4 active not recruiting Methocarbamol in Ventral and Inguinal HR
NCT05076110 21-003441 Ph 4 recruiting Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
NCT02432456 results posted PRO00024679 Ph 4 completed Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients
NCT02831569 results posted 1387.1 Ph 3 completed Japanese IP-TN Trial
NCT02665286 results posted 2015-5903 Ph 4 completed Orphenadrine and Methocarbamol for LBP
🔬

Active Pipeline

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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

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.

ROBAXIN FDA Label Details

Indications & Usage

FDA Label (PDF)

ROBAXIN is indicated for the treatment of Musculoskeletal Conditions.

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Data Sources

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