Data updated: Nov 8, 2026
GUAIFENESIN · GUARDIAN DRUG
Respiratory
Approved 2002-07-12
9
Indications
--
Phase 3 Trials
24
Years on Market
Details
- Status
- Prescription
- First Approved
- 2002-07-12
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
GUARDIAN DRUG PHARMAZONE Dr. Reddy's GRANULES PERRIGO R AND D OHM LABS INC Teva AMNEAL PHARMS Aurobindo Pharma
Active Ingredient: GUAIFENESIN
Website: ↗
GUAIFENESIN Approval History
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
35 FDA actions from 2011 to 2026
Nov 2026 SUPPL
Label · Labeling
May 2025 SUPPL
Mfg · Manufacturing (CMC)
Apr 2025 SUPPL
Mfg · Manufacturing (CMC)
Jan 2025 SUPPL
Label
Aug 2023 ORIGINAL
Update
Jul 2023 SUPPL
Label
Dec 2022 SUPPL
Label
Mar 2022 ORIGINAL
Update
May 2020 ORIGINAL
Update
Oct 2019 ORIGINAL
Update
Jul 2018 ORIGINAL
Update
Jul 2018 ORIGINAL
Update
Sep 2015 ORIGINAL
Update
Mar 2015 SUPPL
Mfg
Nov 2011 ORIGINAL
Update
What GUAIFENESIN Treats
9 FDA approvalsOriginally approved for its first indication in 2011 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Nov 2011)
- • Approved indication (Sep 2015)
- • Approved indication (Sep 2017)Letter
- • Approved indication (Jul 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Oct 2019)
- • Approved indication (May 2020)
- • Approved indication (Mar 2022)
- • Approved indication (Aug 2023)
📋
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 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.