Application 205766
- Type
- NDA
- Sponsor
- LINDE NORTH AMERICA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITROGEN, NF | NITROGEN | 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 |
|---|---|---|---|---|---|---|
| NITROGEN | NITROGEN | Airweld, Inc | 55e1aa68-e3e4-4862-a16c-18bcaed5be18 | 2024-10-08 | 205766 NDA205766 | |
| NITROGEN | NITROGEN | Noble Gas Solutions, Inc. | af2bcc03-89aa-48aa-8749-cb53be56432e | 2024-10-06 | 205766 NDA205766 17819-1066 | |
| NITROGEN | NITROGEN | ADF Welding & Medical, Inc. | 174cb8ea-66fb-4d0b-920f-01fba9537ee9 | 2024-10-02 | 205766 NDA205766 |
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 |
|---|---|---|---|---|---|
| 10218-102 | NITROGEN | NITROGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10218-102 | NITROGEN | NITROGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10218-102 | NITROGEN | NITROGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10218-102 | NITROGEN | NITROGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10218-102 | NITROGEN | NITROGEN | CEE-KAY SUPPLY, INC. | NDA | Current |
| 10297-200 | Nitrogen | Nitrogen | A OX Welding Supply Company Inc. | NDA | Current |
| 10297-200 | Nitrogen | Nitrogen | A OX Welding Supply Company Inc. | NDA | Current |
| 10526-003 | Nitrogen | Nitrogen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-006 | Nitrogen | Nitrogen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-006 | Nitrogen | Nitrogen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-006 | Nitrogen | Nitrogen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-006 | Nitrogen | Nitrogen | Haun Welding Supply, Inc. | NDA | Current |
| 10526-006 | Nitrogen | Nitrogen | Haun Welding Supply, Inc. | NDA | Current |
| 10927-101 | NITROGEN | NITROGEN | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-106 | NITROGEN | NITROGEN | PURITY CYLINDER GASES INC | NDA | Current |
| 11043-002 | Nitrogen | Nitrogen | S. J. Smith Co., Inc. | NDA | Current |
| 11043-002 | Nitrogen | Nitrogen | S. J. Smith Co., Inc. | NDA | Current |
| 11043-002 | Nitrogen | Nitrogen | S. J. Smith Co., Inc. | NDA | Current |
| 11043-002 | Nitrogen | Nitrogen | S. J. Smith Co., Inc. | NDA | Current |
| 11043-002 | Nitrogen | Nitrogen | S. J. Smith Co., Inc. | NDA | Current |
| 11999-002 | NITROGEN | NITROGEN | Welders Supply Company | NDA | Current |
| 11999-002 | NITROGEN | NITROGEN | Welders Supply Company | NDA | Current |
| 11999-002 | NITROGEN | NITROGEN | Welders Supply Company | NDA | Current |
| 11999-002 | NITROGEN | NITROGEN | Welders Supply Company | NDA | Current |
| 11999-002 | NITROGEN | NITROGEN | Welders Supply Company | NDA | Current |
| 11999-002 | NITROGEN | NITROGEN | Welders Supply Company | NDA | Current |
| 12121-006 | NITROGEN | NITROGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-006 | NITROGEN | NITROGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-006 | NITROGEN | NITROGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-006 | NITROGEN | NITROGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-006 | NITROGEN | NITROGEN | Badger Welding Supplies, Inc | NDA | Current |
| 12121-006 | NITROGEN | NITROGEN | Badger Welding Supplies, Inc | NDA | Current |
| 14208-003 | NITROGEN | NITROGEN | California Tool & Welding Supply, LLC | NDA | Current |
| 14208-003 | NITROGEN | NITROGEN | California Tool & Welding Supply, LLC | NDA | Current |
| 14208-003 | NITROGEN | NITROGEN | California Tool & Welding Supply, LLC | NDA | Current |
| 14208-003 | NITROGEN | NITROGEN | California Tool & Welding Supply, LLC | NDA | Current |
| 14208-003 | NITROGEN | NITROGEN | California Tool & Welding Supply, LLC | NDA | Current |
| 14961-003 | Nitrogen | Nitrogen | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-007 | Nitrogen | Nitrogen | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-007 | Nitrogen | Nitrogen | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-007 | Nitrogen | Nitrogen | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-007 | Nitrogen | Nitrogen | Haun Specialty Gases, Inc. | NDA | Current |
| 15687-001 | Nitrogen | Nitrogen | Big Branch Breeders Service | NDA | Current |
| 15687-001 | Nitrogen | Nitrogen | Big Branch Breeders Service | NDA | Current |
| 15687-001 | Nitrogen | Nitrogen | Big Branch Breeders Service | NDA | Current |
| 15687-001 | Nitrogen | Nitrogen | Big Branch Breeders Service | NDA | Current |
| 15687-001 | Nitrogen | Nitrogen | Big Branch Breeders Service | NDA | Current |
| 17575-006 | Nitrogen | Nitrogen | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-006 | Nitrogen | Nitrogen | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-006 | Nitrogen | Nitrogen | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-006 | Nitrogen | Nitrogen | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-006 | Nitrogen | Nitrogen | AGL Inhalation Therapy Co. | NDA | Current |
| 17819-1066 | NITROGEN | NITROGEN | Noble Gas Solutions, Inc. | NDA | Current |
| 17819-1066 | NITROGEN | NITROGEN | Noble Gas Solutions, Inc. | NDA | Current |
| 17819-1066 | NITROGEN | NITROGEN | Noble Gas Solutions, Inc. | NDA | Current |
| 17819-1066 | NITROGEN | NITROGEN | Noble Gas Solutions, Inc. | NDA | Current |
| 33335-002 | Nitrogen | Nitrogen | WELSCO, INC. | NDA | Current |
| 33335-002 | Nitrogen | Nitrogen | WELSCO, INC. | NDA | Current |
| 33335-002 | Nitrogen | Nitrogen | WELSCO, INC. | NDA | Current |
| 33335-002 | Nitrogen | Nitrogen | WELSCO, INC. | NDA | Current |
| 33335-002 | Nitrogen | Nitrogen | WELSCO, INC. | NDA | Current |
| 33335-002 | Nitrogen | Nitrogen | WELSCO, INC. | NDA | Current |
| 42068-002 | Nitrogen | Nitrogen | Jackson Welding Supply Co Inc. | NDA | Current |
| 42068-002 | Nitrogen | Nitrogen | Jackson Welding Supply Co Inc. | NDA | Current |
| 42068-002 | Nitrogen | Nitrogen | Jackson Welding Supply Co Inc. | NDA | Current |
| 42068-002 | Nitrogen | Nitrogen | Jackson Welding Supply Co Inc. | NDA | Current |
| 42068-002 | Nitrogen | Nitrogen | Jackson Welding Supply Co Inc. | NDA | Current |
| 42241-002 | Nitrogen | Nitrogen | INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. | NDA | Current |
| 42241-002 | Nitrogen | Nitrogen | INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. | NDA | Current |
| 42241-002 | Nitrogen | Nitrogen | INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. | NDA | Current |
| 42241-002 | Nitrogen | Nitrogen | INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. | NDA | Current |
| 42241-002 | Nitrogen | Nitrogen | INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. | NDA | Current |
| 42241-002 | Nitrogen | Nitrogen | INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. | NDA | Current |
| 47632-0003 | NITROGEN | NITROGEN | O.E. Meyer Company | NDA | Current |
| 47632-0003 | NITROGEN | NITROGEN | O.E. Meyer Company | NDA | Current |
| 47632-0003 | NITROGEN | NITROGEN | O.E. Meyer Company | NDA | Current |
| 47632-0003 | NITROGEN | NITROGEN | O.E. Meyer Company | NDA | Current |
| 47632-0003 | NITROGEN | NITROGEN | O.E. Meyer Company | NDA | Current |
| 47632-0003 | NITROGEN | NITROGEN | O.E. Meyer Company | NDA | Current |
| 48273-006 | NITROGEN | NITROGEN | Keen Compressed Gas Co. Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10497 | ORIG | 2015-10-02 |