Application 206826
- Type
- NDA
- Sponsor
- LINDE GAS NORTH AMERICA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HELIUM, USP | HELIUM | GAS;INHALATION | N/A | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10014-004 | Helium | Helium | Aero All Gas Company | NDA | Current |
| 10014-004 | Helium | Helium | Aero All Gas Company | NDA | Current |
| 10014-004 | Helium | Helium | Aero All Gas Company | NDA | Current |
| 10014-004 | Helium | Helium | Aero All Gas Company | NDA | Current |
| 10014-004 | Helium | Helium | Aero All Gas Company | NDA | Current |
| 14961-005 | Helium | Helium | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-005 | Helium | Helium | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-005 | Helium | Helium | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-005 | Helium | Helium | Haun Specialty Gases, Inc. | NDA | Current |
| 14961-005 | Helium | Helium | Haun Specialty Gases, Inc. | NDA | Current |
| 25373-010 | Helium | Helium | Linde Gas North America LLC | NDA | Current |
| 25373-010 | Helium | Helium | Linde Gas & Equipment Inc. | NDA | Current |
| 48273-011 | Helium | Helium | Keen Compressed Gas Co. Inc. | NDA | Current |
| 48273-011 | Helium | Helium | Keen Compressed Gas Co. Inc. | NDA | Current |
| 48273-011 | Helium | Helium | Keen Compressed Gas Co. Inc. | NDA | Current |
| 48273-011 | Helium | Helium | Keen Compressed Gas Co. Inc. | NDA | Current |
| 48273-011 | Helium | Helium | Keen Compressed Gas Co. Inc. | NDA | Current |
| 48273-011 | Helium | Helium | Keen Compressed Gas Co. Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10595 | ORIG | 2015-10-02 |