GOLYTELY
Details
- Status
- Prescription
- First Approved
- 1984-07-13
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
Companies
GOLYTELY Approval History
What GOLYTELY Treats
1 FDA approvalsOriginally approved for its first indication in 1984 .
- Other (1)
Other
(1 approval)- • Approved indication (Jul 1984)
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
GOLYTELY FDA Label Details
ProIndications & Usage
FDA Label (PDF)GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. GoLYTELY is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.