Application 205804
- Type
- NDA
- Sponsor
- PURITY CYLINDER GASES, INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEDICAL AIR, USP | MEDICAL AIR | 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 |
|---|---|---|---|---|---|---|
| AIR | AIR | PURITY CYLINDER GASES INC | 68d425b6-fc78-45ad-9d84-e1bfb15d520a | 2025-12-01 | 205804 NDA205804 10927-104 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10927-104 | AIR | AIR | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-104 | AIR | AIR | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-104 | AIR | AIR | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-104 | AIR | AIR | PURITY CYLINDER GASES INC | NDA | Current |
| 10927-104 | AIR | AIR | PURITY CYLINDER GASES INC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10504 | ORIG | 2015-09-29 |