Data updated: May 26, 2026
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (guaifenesin)
Pain
Approved 2015-05-27
6
Indications
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2015-05-27
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
Website: ↗
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
14 FDA actions from 2015 to 2022
Aug 2022 ORIGINAL
Update
Feb 2022 ORIGINAL
Update
Apr 2020 ORIGINAL
Update
Mar 2020 ORIGINAL
Update
Apr 2018 SUPPL
Label
Dec 2017 ORIGINAL
Update
What GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE Treats
6 FDA approvalsOriginally approved for its first indication in 2015 . Covers 6 distinct patient populations.
- Other (6)
Other
(6 approvals)- • Approved indication (May 2015)Letter
- • Approved indication (Dec 2017)
- • Approved indication (Mar 2020)
- • Approved indication (Apr 2020)
- • Approved indication (Feb 2022)
- • Approved indication (Aug 2022)
📋
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01202279 Wait and See results posted | 2009-MUCD-001 | Ph 4 | completed | Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI |
| NCT01364467 results posted | HM13538 | Ph 2 | completed | The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study |
🔬
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.
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.