Data updated: Mar 10, 2026
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350
Approved 2006-05-04
14
Indications
--
Phase 3 Trials
19
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2006-05-04
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
Companies
BRECKENRIDGE PHARM PADDOCK LLC Viatris STRIDES PHARMA ANNORA PHARMA NOVEL LABS INC NEXGEN PHARMA INC LGM PHARMA ANI PHARMS Aurobindo Pharma STRIDES PHARMA INTL Teva SHREE HARI INTL PPI-DAC NUVO PHARMS INC
Active Ingredient: POLYETHYLENE GLYCOL 3350
Website: ↗
POLYETHYLENE GLYCOL 3350 Approval History
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What POLYETHYLENE GLYCOL 3350 Treats
14 FDA approvalsOriginally approved for its first indication in 2006 . Covers 14 distinct patient populations.
- Other (14)
Other
(14 approvals)- • Approved indication (May 2006)
- • Approved indication (May 2006)
- • Approved indication (May 2006)
- • Approved indication (Sep 2006)
- • Approved indication (Oct 2009)Letter
- • Approved indication (Oct 2009)
- • Approved indication (Oct 2009)
- • Approved indication (Dec 2012)
- • Approved indication (Jan 2013)
- • Approved indication (Dec 2015)
- • Approved indication (Aug 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Apr 2018)
- • Approved indication (Apr 2021)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
POLYETHYLENE GLYCOL 3350 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.