TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ROBAXIN

METHOCARBAMOL
Approved 1957-07-16
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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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

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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

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Indications & Usage

FDA Label (PDF)

The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

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Data Sources

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