TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

LACTULOSE

LACTULOSE
Approved 1992-05-29
Jump to: Indications Approvals Trials Competitors Safety Patents
17
Indications
--
Phase 3 Trials
33
Years on Market

Details

Status
Discontinued
First Approved
1992-05-29
Routes
ORAL, ORAL, RECTAL
Dosage Forms
SOLUTION, FOR SOLUTION

Companies

VISTAPHARM LLC PHARMOBEDIENT BAJAJ Fresenius Kabi APOZEAL PHARMS MORTON GROVE PACO ROXANE Aurobindo Pharma ANI PHARMS SOLVAY SCIEGEN PHARMS PAI HOLDINGS Hikma PHARM ASSOC CUMBERLAND PHARMS LANNETT CO INC CHARTWELL RX TARO PAI HOLDINGS PHARM
Active Ingredient: LACTULOSE

LACTULOSE Approval History

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What LACTULOSE Treats

17 FDA approvals

Originally approved for its first indication in 1992 . Covers 17 distinct patient populations.

  • Other (17)
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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

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.

LACTULOSE FDA Label Details

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Data Sources

FDA Approval: ANDA074138 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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