Data updated: Mar 10, 2026
HELIUM, USP
HELIUM
Approved 2013-07-14
14
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2013-07-14
- Routes
- INHALATION
- Dosage Forms
- GAS
Companies
A-OX WELDING SUPPLY CO, INC. NORCO INC AIR LIQUIDE HEALTHCARE AMERICA CORP WESTAIR GASES & EQUIPMENT INC LINDE GAS NORTH AMERICA LLC AIRGAS USA LLC ILMO Products Company MATHESON TRI-GAS INC AIR PRODUCTS AND CHEMICALS INC PRAXAIR DISTRIBUTION MID-ATLANTIC LLC NEXAIR LLC ROBERTS OXYGEN CO INC A G L WELDING SUPPLY CO INC PRAXAIR INC GENERAL AIR SERVICE & SUPPLY COMPANY PRAXAIR DISTRIBUTION INC
Active Ingredient: HELIUM
Website: ↗
HELIUM, USP Approval History
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What HELIUM, USP Treats
14 FDA approvalsOriginally approved for its first indication in 2013 . Covers 14 distinct patient populations.
- Other (14)
Other
(14 approvals)- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Aug 2013)Letter
- • Approved indication (Sep 2013)
- • Approved indication (Mar 2014)Letter
- • Approved indication (Feb 2016)Letter
- • Approved indication (Apr 2018)Letter
- • Approved indication (Oct 2018)Letter
- • Approved indication (Jul 2019)Letter
- • Approved indication (Aug 2019)Letter
- • Approved indication (Oct 2019)Letter
- • Approved indication (Jun 2020)Letter
- • Approved indication (Jul 2021)Letter
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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.
HELIUM, USP FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.