TheraRadar
Data updated: May 26, 2026

SORBITOL 3% IN PLASTIC CONTAINER (sorbitol)

Pain Approved 1980-05-30

SORBITOL 3% IN PLASTIC CONTAINER is indicated for the treatment of Irregular Bowel Movements; Pain; Weakness; Nausea.

Source: FDA Label • Baxter
1
Indication
--
Phase 3 Trials
45
Years on Market

Details

Status
Discontinued
First Approved
1980-05-30
Routes
IRRIGATION
Dosage Forms
SOLUTION

Companies

Active Ingredient: SORBITOL

SORBITOL 3% IN PLASTIC CONTAINER Approval History

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Original
New Indication
New Form
Label Update
42 FDA actions from 1980 to 2004
Mar 2004 SUPPL
Label · Labeling
Aug 2003 SUPPL
Label · Labeling
Sep 2002 SUPPL
Label · Labeling

What SORBITOL 3% IN PLASTIC CONTAINER Treats

4 indications

SORBITOL 3% IN PLASTIC CONTAINER is approved for 4 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Irregular Bowel Movements
  • Pain
  • Weakness
  • Nausea
Source: FDA Label

SORBITOL 3% IN PLASTIC CONTAINER Competitive Set

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Drugs Similar to SORBITOL 3% IN PLASTIC CONTAINER

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SORBITOL 3.3% IN PLASTIC CONTAINER
SORBITOL
4 shared
B BRAUN
Shared indications:
Irregular Bowel MovementsPainWeakness +1 more
ACUVAIL
KETOROLAC TROMETHAMINE
1 shared
AbbVie
Shared indications:
AKYNZEO
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HELSINN HLTHCARE
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT06826079 SNCCTGC Union01 Ph 2, Ph 3 recruiting Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patients With Locally Advanced Gastric Cancer
NCT04330326 NAFLD 309 Ph 2 completed Metabolic Cofactor Supplementation in Obese Patients With Non-Alcoholic Fatty Liver Disease
NCT04044131 Metabolic Cofactor Study Ph 2 completed Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) Patients
NCT02634073 results posted 204857 Ph 4 completed A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
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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

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.

SORBITOL 3% IN PLASTIC CONTAINER FDA Label Details

Indications & Usage

SORBITOL 3% IN PLASTIC CONTAINER is indicated for the treatment of Irregular Bowel Movements; Pain; Weakness; Nausea.

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Data Sources

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