TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

LIBRAX

CHLORDIAZEPOXIDE HYDROCHLORIDE
Immunology Approved 1966-09-01
1
Indication
--
Phase 3 Trials
59
Years on Market

Details

Status
Prescription
First Approved
1966-09-01
Routes
ORAL
Dosage Forms
CAPSULE

Companies

LIBRAX Approval History

Loading approval history...

What LIBRAX Treats

4 indications

LIBRAX is approved for 4 conditions since its original approval in 1966. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Gastrointestinal Disorder
  • Peptic Ulcer
  • Irritable Bowel Syndrome
  • Enterocolitis
Source: FDA Label

LIBRAX Boxed Warning

RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRE...

Drugs Similar to LIBRAX

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE
4 shared
Aurobindo Pharma
Shared indications:
Gastrointestinal DisorderPeptic UlcerIrritable Bowel Syndrome +1 more
LIBRIUM
CHLORDIAZEPOXIDE HYDROCHLORIDE
4 shared
VALEANT PHARM INTL
Shared indications:
Gastrointestinal DisorderPeptic UlcerIrritable Bowel Syndrome +1 more
ALOSETRON HYDROCHLORIDE
ALOSETRON HYDROCHLORIDE
1 shared
RISING
Shared indications:
Irritable Bowel Syndrome
AMITIZA
LUBIPROSTONE
1 shared
SUCAMPO PHARMA LLC
Shared indications:
Irritable Bowel Syndrome
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)
DICYCLOMINE HYDROCHLORIDE
1 shared
Hikma
Shared indications:
Irritable Bowel Syndrome
EPIOXA HD/EPIOXA KIT
RIBOFLAVIN 5'-PHOSPHATE SODIUM
1 shared
GLAUKOS
Shared indications:
Gastrointestinal Disorder
GLYRX-PF
GLYCOPYRROLATE
1 shared
EXELA PHARMA
Shared indications:
Peptic Ulcer
LINZESS
LINACLOTIDE
1 shared
AbbVie
Shared indications:
Irritable Bowel Syndrome
LOTRONEX
ALOSETRON HYDROCHLORIDE
1 shared
LEGACY PHARMA
Shared indications:
Irritable Bowel Syndrome
METHSCOPOLAMINE BROMIDE
METHSCOPOLAMINE BROMIDE
1 shared
UNICHEM
Shared indications:
Peptic Ulcer
PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA
RIBOFLAVIN 5'-PHOSPHATE SODIUM
1 shared
GLAUKOS
Shared indications:
Gastrointestinal Disorder
ROBINUL
GLYCOPYRROLATE
1 shared
CASPER PHARMA LLC
Shared indications:
Peptic Ulcer
ROBINUL FORTE
GLYCOPYRROLATE
1 shared
CASPER PHARMA LLC
Shared indications:
Peptic Ulcer
TRULANCE
PLECANATIDE
1 shared
SALIX
Shared indications:
Irritable Bowel Syndrome
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

Full development history with FDA approval milestones

Loading...
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.

LIBRAX FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

: Librax is indicated to control emotional and somatic factors in gastrointestinal disorders. Librax may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

⚠️ BOXED WARNING

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patient...

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

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