Application 205767
- Type
- NDA
- Sponsor
- LINDE NORTH AMERICA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYGEN, USP | OXYGEN | GAS;INHALATION | N/A | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| OXYGEN | OXYGEN | Noble Gas Solutions, Inc. | 13ce9fe8-ca43-4564-87b2-f8e97570dcfd | 2024-10-06 | 205767 NDA205767 | |
| Oxygen | OXYGEN | ADF Welding & Medical, Inc. | 01efe36d-5281-4ede-bc30-9a1727a86a83 | 2024-10-02 | 205767 NDA205767 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10073-111 | oxygen | oxygen | Oz Arc/gas Equipment & Supply, Inc. | NDA | Current |
| 10073-111 | oxygen | oxygen | Oz Arc/gas Equipment & Supply, Inc. | NDA | Current |
| 10073-111 | oxygen | oxygen | Oz Arc/gas Equipment & Supply, Inc. | NDA | Current |
| 10073-111 | oxygen | oxygen | Oz Arc/gas Equipment & Supply, Inc. | NDA | Current |
| 10073-111 | oxygen | oxygen | Oz Arc/gas Equipment & Supply, Inc. | NDA | Current |
| 10189-001 | Oxygen | Oxygen | Butler Gas Products Company | NDA | Current |
| 10189-001 | Oxygen | Oxygen | Butler Gas Products Company | NDA | Current |
| 10189-001 | Oxygen | Oxygen | Butler Gas Products Company | NDA | Current |
| 10189-001 | Oxygen | Oxygen | Butler Gas Products Company | NDA | Current |
| 10189-001 | Oxygen | Oxygen | Butler Gas Products Company | NDA | Current |
| 10189-001 | Oxygen | Oxygen | Butler Gas Products Company | NDA | Current |
| 10218-001 | OXYGEN | OXYGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10218-001 | OXYGEN | OXYGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10218-001 | OXYGEN | OXYGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10218-001 | OXYGEN | OXYGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10218-001 | OXYGEN | OXYGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10297-070 | Heliox | Heliox | A-OX WELDING SUPPLY CO., INC. | NDA | Current |
| 10297-080 | Heliox | Heliox | A-OX WELDING SUPPLY CO., INC. | NDA | Current |
| 10297-100 | Oxygen | Oxygen | A OX Welding Supply Company Inc. | NDA | Current |
| 10297-100 | Oxygen | Oxygen | A OX Welding Supply Company Inc. | NDA | Current |
| 10297-103 | Air | Air | A-OX Welding Supply Co., Inc. | NDA | Current |
| 10526-001 | Oxygen | Oxygen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-005 | Oxygen | Oxygen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-005 | Oxygen | Oxygen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-005 | Oxygen | Oxygen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-005 | Oxygen | Oxygen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-005 | Oxygen | Oxygen | Haun Welding Supply, Inc. | NDA | Current |
| 10736-202 | Oxygen | Oxygen | MEDICAL-TECHNICAL GASES, INC. | NDA | Current |
| 10927-003 | OXYGEN | OXYGEN | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-003 | OXYGEN | OXYGEN | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-003 | OXYGEN | OXYGEN | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-003 | OXYGEN | OXYGEN | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-103 | OXYGEN | OXYGEN | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-105 | OXYGEN | OXYGEN | PURITY CYLINDER GASES INC | NDA | Current |
| 11043-001 | Oxygen | Oxygen | S. J. Smith Co., Inc. | NDA | Current |
| 11043-001 | Oxygen | Oxygen | S. J. Smith Co., Inc. | NDA | Current |
| 11043-001 | Oxygen | Oxygen | S. J. Smith Co., Inc. | NDA | Current |
| 11043-001 | Oxygen | Oxygen | S. J. Smith Co., Inc. | NDA | Current |
| 11043-001 | Oxygen | Oxygen | S. J. Smith Co., Inc. | NDA | Current |
| 11999-001 | OXYGEN | OXYGEN | Welders Supply Company | NDA | Current |
| 11999-001 | OXYGEN | OXYGEN | Welders Supply Company | NDA | Current |
| 11999-001 | OXYGEN | OXYGEN | Welders Supply Company | NDA | Current |
| 11999-001 | OXYGEN | OXYGEN | Welders Supply Company | NDA | Current |
| 11999-001 | OXYGEN | OXYGEN | Welders Supply Company | NDA | Current |
| 11999-001 | OXYGEN | OXYGEN | Welders Supply Company | NDA | Current |
| 12121-001 | OXYGEN | OXYGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-001 | OXYGEN | OXYGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-001 | OXYGEN | OXYGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-001 | OXYGEN | OXYGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-001 | OXYGEN | OXYGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-001 | OXYGEN | OXYGEN | Badger Welding Supplies, Inc | NDA | Current |
| 14208-532 | OXYGEN | OXYGEN | California Tool and Welding Supply, LLC | NDA | Current |
| 14208-532 | OXYGEN | OXYGEN | California Tool and Welding Supply, LLC | NDA | Current |
| 14208-532 | OXYGEN | OXYGEN | California Tool and Welding Supply, LLC | NDA | Current |
| 14208-532 | OXYGEN | OXYGEN | California Tool and Welding Supply, LLC | NDA | Current |
| 14208-532 | OXYGEN | OXYGEN | California Tool and Welding Supply, LLC | NDA | Current |
| 14208-532 | OXYGEN | OXYGEN | California Tool and Welding Supply, LLC | NDA | Current |
| 14961-001 | Oxygen | Oxygen | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-004 | Air | Air | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-004 | Air | Air | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-004 | Air | Air | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-004 | Air | Air | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-004 | Air | Air | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-006 | Oxygen | Oxygen | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-006 | Oxygen | Oxygen | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-006 | Oxygen | Oxygen | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-006 | Oxygen | Oxygen | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-006 | Oxygen | Oxygen | Haun Specialty Gases, Inc. | NDA | Current |
| 17575-001 | Oxygen | Oxygen | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-001 | Oxygen | Oxygen | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-001 | Oxygen | Oxygen | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-001 | Oxygen | Oxygen | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-001 | Oxygen | Oxygen | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-020 | Carbon Dioxide Oxygen Mixture 5/95 | Carbon Dioxide Oxygen Mixture 5/95 | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-020 | Carbon Dioxide Oxygen Mixture 5/95 | Carbon Dioxide Oxygen Mixture 5/95 | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-020 | Carbon Dioxide Oxygen Mixture 5/95 | Carbon Dioxide Oxygen Mixture 5/95 | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-020 | Carbon Dioxide Oxygen Mixture 5/95 | Carbon Dioxide Oxygen Mixture 5/95 | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-020 | Carbon Dioxide Oxygen Mixture 5/95 | Carbon Dioxide Oxygen Mixture 5/95 | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-038 | Oxygen Helium Mixture 30/70 | Oxygen Helium Mixture 30/70 | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-038 | Oxygen Helium Mixture 30/70 | Oxygen Helium Mixture 30/70 | AGL Inhalation Therapy Co. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32719 | ORIG | 2015-10-02 |