Application 214375
- Type
- NDA
- Sponsor
- POLAREAN INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XENOVIEW | XENON XE 129 HYPERPOLARIZED | INHALANT;ORAL | 1000ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 80534-1000 | XENOVIEW | xenon Xe 129 hyperpolarized | Polarean, Inc. | NDA | Current |
| 80534-6350 | XENOVIEW | xenon Xe 129 hyperpolarized | Polarean, Inc. | NDA | Current |