Application 205820
- Type
- NDA
- Sponsor
- NORCO 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 | Norco, Inc. | f47d15a8-f534-4ef2-bc3d-26a05d541220 | 2025-12-12 | 205820 NDA205820 42602-001 | |
| MEDICAL AIR | OXYGEN | Norco, Inc. | b54cea1e-2c36-455b-b1a2-a5472d873726 | 2025-08-31 | 205820 NDA205820 42602-004 | |
| OXYGEN | OXYGEN | Logan Health | d87e6283-9639-42ae-acba-9d000086b466 | 2025-02-19 | 205820 NDA205820 60696-1234 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42602-001 | OXYGEN | OXYGEN | Norco, Inc. | NDA | Current |
| 42602-001 | OXYGEN | OXYGEN | Norco, Inc. | NDA | Current |
| 42602-001 | OXYGEN | OXYGEN | Norco, Inc. | NDA | Current |
| 42602-004 | MEDICAL AIR | OXYGEN | Norco, Inc. | NDA | Current |
| 42602-004 | MEDICAL AIR | OXYGEN | Norco, Inc. | NDA | Current |
| 60696-1234 | OXYGEN | OXYGEN | Kalispell Medical Equipment | NDA | Current |
| 60696-1234 | OXYGEN | OXYGEN | Logan Health | NDA | Current |
| 60696-1234 | OXYGEN | OXYGEN | Logan Health | NDA | Current |
| 60696-1234 | OXYGEN | OXYGEN | Kalispell Medical Equipment | NDA | Current |
| 60696-1234 | OXYGEN | OXYGEN | Kalispell Medical Equipment | NDA | Current |
| 60696-1234 | OXYGEN | OXYGEN | Logan Health | NDA | Current |
| 65567-001 | Oxygen | Oxygen | Central Montana Medical Facilities, Inc. | NDA | Current |
| 68540-001 | Oxygen | Oxygen | Price Rite Medical Equipment, Inc. | NDA | Current |
| 68540-001 | Oxygen | Oxygen | Price Rite Medical Equipment, Inc. | NDA | Current |
| 68540-001 | Oxygen | Oxygen | Price Rite Medical Equipment, Inc. | NDA | Current |
| 68540-001 | Oxygen | Oxygen | Price Rite Medical Equipment, Inc. | NDA | Current |
| 68540-001 | Oxygen | Oxygen | Price Rite Medical Equipment, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32736 | ORIG | 2015-10-01 |