Data updated: Mar 10, 2026
OXYGEN, USP
OXYGEN
Approved 2013-06-16
16
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2013-06-16
- Routes
- INHALATION
- Dosage Forms
- GAS
Companies
AIR LIQUID INDUSTRIAL US LP AIR LIQUIDE AMERICA LP PRAXAIR INC UNIVERSAL INDUSTRIAL GASES, INC PRAXAIR CANADA INC ABSOLUTE AIR, LLC NORCO INC MATHESON TRI-GAS INC LINDE GAS PUERTO RICO INC AIR PRODUCTS AND CHEMICALS INC LINDE NORTH AMERICA INC AIRGAS USA LLC ASPEN AIR AIR LIQUIDE CANADA INC AIR LIQUIDE LARGE INDUSTRIES US LP AIRGAS MERCHANTS GASES LLC PRAXAIR MEXICO CRISTAL ASU LLC
Active Ingredient: OXYGEN
Website: ↗
OXYGEN, USP Approval History
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What OXYGEN, USP Treats
16 FDA approvalsOriginally approved for its first indication in 2013 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Jun 2013)Letter
- • Approved indication (Jun 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Aug 2013)Letter
- • Approved indication (Aug 2013)Letter
- • Approved indication (Sep 2013)
- • Approved indication (Sep 2017)Letter
- • Approved indication (Aug 2018)Letter
- • Approved indication (Sep 2018)Letter
- • Approved indication (Jun 2020)Letter
- • Approved indication (Jun 2022)Letter
🔬
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.
OXYGEN, 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.