Application 205819
- Type
- NDA
- Sponsor
- NORCO INC
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17575-005 | Helium | Helium | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-005 | Helium | Helium | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-005 | Helium | Helium | AGL Inhalation Therapy Co. | NDA | Current |
| 17575-005 | Helium | Helium | AGL Inhalation Therapy Co. | NDA | Current |
| 42602-002 | HELIUM | HELIUM | Norco, Inc. | NDA | Current |
| 42602-002 | HELIUM | HELIUM | Norco, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32735 | ORIG | 2015-10-06 |