Application 213609
- Type
- NDA
- Sponsor
- ROBERTS OXYGEN CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 000 | HELIUM, USP | HELIUM | 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 |
|---|---|---|---|---|---|---|
| Helium | HELIUM | Roberts Oxygen Company, Inc. | 554faa48-7fc2-4d1a-b223-82cf107b144f | 2025-11-17 | 213609 NDA213609 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60177 | ORIG | 2019-10-01 |