Skip to contentApplication 018327
- Type
- NDA
- Sponsor
- CURIUM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XENON XE 133 | XENON XE-133 | GAS;INHALATION | 10mCi/VIAL | No | No |
| 002 | XENON XE 133 | XENON XE-133 | GAS;INHALATION | 20mCi/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69945-097 | Xenon, Xe-133 | Xenon | Curium US LLC | NDA | Current |
| 69945-097 | Xenon, Xe-133 | Xenon | Curium US LLC | NDA | Current |
| 69945-097 | Xenon, Xe-133 | Xenon | Curium US LLC | NDA | Current |
| 69945-098 | Xenon, Xe-133 | Xenon | Curium US LLC | NDA | Current |
| 69945-098 | Xenon, Xe-133 | Xenon | Curium US LLC | NDA | Current |
| 69945-098 | Xenon, Xe-133 | Xenon | Curium US LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 11204 | SUPPL | 2016-03-14 |